BETTER RESPIRATORY EQUIPMENT USING ADVANCED …BETTER RESPIRATORY EQUIPMENT USING ADVANCED TECHNOLOGIES FOR HEALTHCARE EMPLOYEES (PROJECT B.R.E.A.T.H.E.) An Interagency Working Group

PROPERTY OF THE UNITED STATES GOVERNMENT

BETTER RESPIRATORY EQUIPMENT USING ADVANCED TECHNOLOGIESFOR HEALTHCARE EMPLOYEES (PROJECT B.R.E.A.T.H.E.)

An Interagency Working Group of the U.S. Federal Government

Disclaimer: The views presented in this report are the authors’ opinions and do not necessarily reflect the views or opinions of the National Center for Occupational Health and Infection Control, the Veterans Health Administration, the National Personal Protective Technology Laboratory, the U.S. Department of Health and Hu-man Services, the Occupational Safety and Health Administration, the National Aeronautics and Space Administration or any of the authors’ or participants’ employers or affiliations. The content in this manuscript should not be construed as an official position of the U.S. Federal Government nor any of the agencies represented by the authors or participants.

Sponsored and Chaired by the Office of Public Health and Environmental Hazards in theVeterans Health Administration at the U.S. Department of Veterans Affairs

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A Report of an Interagency Working Group of the U.S. Federal Government

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Disclaimer: The views presented in this report are the authors’ opinions and do not necessarily reflect the views or opinions of the National Center for Occupational Health and Infection Control, the Veterans Health Administration, the National Personal Protective Technology Laboratory, the U.S. Department of Health and Human Services, the Occupational Safety and Health Administration, the National Aeronautics and Space Administration or any of the authors’ or participants’ employers or affiliations. The content in this manuscript should not be construed as an official position of the U.S. Federal Government nor any of the agencies represented by the authors or participants.

2 • PROJECT B.R.E.A.T.H.E. REPORT

BETTER RESPIRATORY EQUIPMENT USING ADVANCED TECHNOLOGIESFOR HEALTHCARE EMPLOYEES (PROJECT B.R.E.A.T.H.E.)

AUTHORED BY:

PROPERTY OF THE UNITED STATES GOVERNMENT

Lewis J. Radonovich, Jr., MD* Raymond Roberge, MD, MPHDirector, National Center for Occupational Health and Infection Research Medical Officer

Control National Personal Protective Technology Lab U.S. Department of Veterans Affairs National Institute for Occupational Safety and HealthVeterans Health Administration Centers for Disease Control and Prevention Office of Public Health and Environmental P.O. Box 18070 Hazards and North Florida/South Georgia Veterans Health 626 Cochrans Mill Road, Building 29

System Pittsburgh, PA 15236 1601 SW Archer Road (151B)Gainesville, FL 32608 Andrew Levinson, MPHEmail: [email protected] Director, Office of Biological Hazards*Corresponding author Occupational Safety and Health Administration Directorate of

Standards and GuidanceAliya Baig, RN, MSN, MPH 200 Constitution Ave. NW, Room N3718Associate, National Center for Occupational Health and Infection Washington, DC 20210

ControlU.S. Department of Veterans Affairs Donald F. DoerrVeterans Health Administration Chief, Biomedical EngineeringOffice of Public Health and Environmental National Aeronautics and Space AdministrationHazards and North Florida/South Georgia Veterans Health John F. Kennedy Space Center

System Kennedy Space Center, FL 32899 1601 SW Archer Road (151B)Gainesville, Florida 32608 Victoria Davey, Ph.D., MPH, RN

Deputy Chief Consultant Ronald E. Shaffer, Ph.D. Office of Public Health and Environmental HazardsChief, Research Branch Veterans Health Administration National Personal Protective Technology Laboratory U.S. Department of Veterans Affairs National Institute for Occupational Safety and Health 1717 H StreetCenters for Disease Control and Prevention Washington, DC 20420P.O. Box 18070 626 Cochrans Mill Road, Building 29 Pittsburgh, PA 15236

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PROJECT B.R.E.A.T.H.E. REPORT • 3

TABLE OF CONTENTS

Content ...............................................................................................................................................................Page List of Authors ......................................................................................................................................................... 2Executive Summary ................................................................................................................................................... 4Introduction ............................................................................................................................................................ 7Background .............................................................................................................................................................. 8Building the “BREATHE Team” ..................................................................................................................................... 9Project BREATHE Consensus Development .....................................................................................................................11Working Group Consensus Statements on Safety and Effectiveness ...................................................................................12 Consensus 1: Safety and Effectiveness ...................................................................................................................12 Consensus 2: Self-Contamination ..........................................................................................................................12 Consensus 3: Fomite Transmission ........................................................................................................................12 Consensus 4: Protection / Respirator Fit ................................................................................................................13 Consensus 5: Blood and Body Fluids .....................................................................................................................13 Consensus 6: Reuse ............................................................................................................................................14 Consensus 7: Repeated Disinfection Durability ........................................................................................................14 Consensus 8: Shelf-Life Durability .........................................................................................................................14 Consensus 9: Gauging Fit ....................................................................................................................................15Working Group Consensus Statements on Supporting, Not Interfering with, Occupational Activities ......................................16 Consensus 10: Hearing Integrity ...........................................................................................................................16 Consensus 11: Speech Intelligibility .....................................................................................................................16 Consensus 12: Visual Field ...................................................................................................................................16 Consensus 13: Facial Visualization ........................................................................................................................17

Consensus 14: Equipment Compatibility .................................................................................................................17 Working Group Consensus Statements on Comfort and Tolerability....................................................................................18

Consensus 15: Breathing Resistance ......................................................................................................................18Consensus 16: Facial Irritation 18Consensus 17: Allergenicity .................................................................................................................................19

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Consensus 18: Facial Pressure ..............................................................................................................................19Consensus 19: Facial Heat ...................................................................................................................................19Consensus 20: Air Exchange .................................................................................................................................19Consensus 21: Moisture Management .....................................................................................................................20Consensus 22: Mass Features ...............................................................................................................................20Consensus 23: Odor ............................................................................................................................................21Consensus 24: Prolonged Tolerability ....................................................................................................................21

Working Group Consensus Statements on Healthcare System Policies and Practices .............................................................22 Consensus 25: Employer Desirability .....................................................................................................................22 Consensus 26: Employee Desirability .....................................................................................................................22 Consensus 27: Patient Desirability ........................................................................................................................22 Consensus 28: Cost Effective for Employers ............................................................................................................23Conclusion and Next Steps.........................................................................................................................................24References ..............................................................................................................................................................25Figure 1: Phases of Project BREATHE ...........................................................................................................................30Figure 2: Institute of Medicine Recommendations for Evidence-Based Performance Measures ................................................31Figure 3: Institute of Medicine Recommendations to Innovate and Strengthen PPE Design, Testing and Certification ...............32Table 1: Current Respirator Performance Requirements issued by Pertinent U.S. Governmental Agencies

and Oversight Organizations ................................................................................................................................33Table 2: Comparison of Current U.S. Governmental Agencies’ and Oversight Organizations’ Respirator

Performance Characteristics with BREATHE Recommendations ....................................................................................39Table 3: Forthcoming Respirator Performance Requirements issued by Pertinent U.S. Governmental Agencies

and Oversight Organization .................................................................................................................................44Appendix A: Project BREATHE Working Group Membership List .........................................................................................46


EXECUTIVE SUMMARY

The Better Respiratory Equipment using Advanced Technologies for Healthcare Employees (Project BREATHE) Working Group (WG) is a U.S. Federal government interagency effort, initiated by the Depart-ment of Veterans Affairs, whose purpose is to develop a set of consensus recommendations that aim to improve respiratory protective equipment used by healthcare workers (HCWs). With representatives from nine (9) Federal departments and agencies, this multi-disciplin-ary team had a broad range of expertise, including pan-demic and emergency preparedness, infectious disease medicine and epidemiology, respirator and personal protective equipment policy and regulation, occupa-tional and environmental medicine, respirator and ma-terials science, infection control, respirator physiology and physics and bio-security. The WG was co-chaired by staff from the Veterans Administration (VA) and the Centers for Disease Control and Prevention (CDC). This report consists of 28 consensus recommendations for consideration by respirator manufacturers, research organizations, consensus standards development organi-zations, and respirator users and their employers.

The activities of the WG build on recommendations issued by the Institute of Medicine (IOM) in Novem-ber 2007 and articulate the next steps that should be taken toward better respiratory protective equipment for HCWs. Together, this set of recommendations con-stitutes an idealized view of the features included in the next generation of respirators for HCWs. Each of 28 consensus recommendations is included in one of four categories of desirable characteristics:

• Respirators should perform their intended functions safely and effectively(9 recommendations)

• Respirators should support, not interfere with, occupational activities(5 recommendations)

• Respirators should be comfortable and tolerable for the duration of wear(10 recommendations)

• Respiratory protective programs should comply with Federal standards and guidelines, state regulations, and local policies(4 recommendations)

These recommendations may be regarded as (a) an ac-tion and research agenda for the Federal government, (b) a guide for the U.S. health care sector that identifies activities which might yield strong returns on their re-source investment, and (c) a research and development roadmap for the next generation of respirators used by the U.S. healthcare workforce.

Reflected in this report is a position held by the WG that clinical assessment tools, such as clinical trials, are preferred over methods performed solely in a labora-tory. However, in many instances clinical assessments are not practical, in which case the use of laboratory tools that have been validated against clinical outcomes, are favored. In cases where neither is available, the WG has made suggestions about the types of assessment methods that should be considered for development and validation. The WG favors the development of a new respirator class called a “B95” (Biological N95) which connotes protection against biological particu-lates. Consensus Recommendations issued by the Proj-ect BREATHE WG include:

Safety and Effectiveness

(1) Respirators should meet current U.S. Federal government standards for respiratory protec-tive devices (e.g., the CDC National Institute for Occupational Safety and Health (NIOSH) N95 single use negative pressure air purifying respirator) and used as part of an Occupation-al Safety and Health Administration (OSHA) compliant respiratory protection program, in-cluding annual fit testing.

(2) (a) A means should be developed to practi-cally don and doff approved respirators with-out self-contamination and (b) A test should be developed, validated and standardized that assesses respirator contamination in a clinical environment.


(3) (a) Designs should be utilized that prevent res-pirator-dependent transmission of infectious pathogens and (b) A test should be developed, validated and standardized that assesses respi-rator-dependent pathogen transmission in a clinical environment.

(4) Respirators should be capable of providing a Simulated Workplace Protection Factor of 100 that is assessed using a standardized and validated measure (e.g., the NIOSH total in-ward leakage test) for a majority (ideally 90%) of healthcare workers wearing a “one-size-fits-all” (or as few sizes as possible) configuration.

(5) Blood and body fluid penetration should be assessed with American Society for Testing and Materials (ASTM) F 1862 - 07: Standard Test Method for Resistance of Surgical Mask to Penetration by Synthetic Blood.

(6) Respirators should be durable enough for the respirator to provide a Simulated Workplace Protection Factor of > 100 after 50 brief work-er-patient encounters, if necessary, during a crisis.

(7) Respirators should be durable enough for the respirator to provide a Simulated Workplace Protection Factor of > 100 after 50 disinfec-tions, each taking 60 seconds or less to com-plete.

(8) Respirators should be durable enough for the respirator to provide a Simulated Workplace Protection Factor of > 100 after being stored in air-conditioned space for at least 10 years at 21-23°C (69-73°F) and 45-55% relative hu-midity.

(9) Respirators should have a manufacturer-spec-ified fit assessment technique (e.g., a user seal check) that is capable of detecting inadequate fit (Simulated Workplace Protection Factor < 100) with at least 75% accuracy during work activities.

No Interference with Occupational Activities

(10) (a) Specific word intelligibility tests should be developed, standardized and validated to more precisely measure the hearing accuracy of words in the healthcare setting and (b) Res-pirator wearers should achieve equivalent or higher scores on hearing acuity tests, on aver-age, when wearing a respirator compared to no respirator.

(11) Respirator wearers should achieve equivalent or higher scores on speaking intelligibility tests, on average, when wearing a respirator compared to no respirator.

(12) (a) Visual fields should be assessed with a stan-dardized and validated tool developed for use in the healthcare environment and (b) Health-care visual field performance criteria should be developed for respirator wearers.

(13) (a) Transparent respirator facepieces should be developed to the extent possible and (b) Transparency should be assessed with an opti-cal clearance test that is standardized and vali-dated.

(14) (a) Respiratory protective equipment should be assessed for inter-equipment compatibil-ity using a practical clinical test that should be developed, standardized, and validated and (b) Healthcare performance criteria for pro-tective equipment compatibility should be de-veloped.

Comfort and Tolerability

(15) (a) Respirators should have a level of breathing resistance that is low enough to be comfort-able and tolerable for (1) ≥ 2 hours of uninter-rupted wear and (2) ≥ 8 hours with 15 minute break periods every 2 hours and (b) Breathing resistance should be < 10 mm H2O pressure drop on average at 85 lpm.

(16) Facial irritation should be assessed using two standardized and validated tests: (a) A clinical assessment utilizing a pain or discomfort scale and (b) A lab-based sensitivity test, such as a transdermal water loss test or an animal skin sensitivity test.


(17) (a) Immune system stimulation should be as-sessed with a standardized and validated test and (b) Performance characteristics for aller-genicity should be developed.

(18) (a) Respirator facial pressure should be low enough to be comfortable and tolerable for (1) ≥ 2 hours of uninterrupted wear and (2) ≥ 8 hours with 15 minute break periods ev-ery 2 hours and (b) Facial pressure should be assessed using two standardized and validated tests: (1) a clinical assessment and (2) a lab-based test.

(19) (a) Respirators should cause a level of facial heat rise that is low enough to be comfortable for (1) ≥ 2 hours of uninterrupted wear and (2) ≥ 8 hours with 15 minute break periods every 2 hours and (b) Facial heat should not exceed a 7°F rise from baseline, on average, when the wearer is under low level exertion at 21-23°C (69-73°F) ambient temperature.

(20) (a) Respirator CO2 dead space retention should be low enough to be comfortable for (1) ≥ 2 hours of uninterrupted wear and (2) ≥ 8 hours with 15 minute break periods every 2 hours and (b) Respirator oral-nasal chamber CO2 levels at end-inhalation should be < 1%, on average.

(21) (a) Respirator humidity should be maintained at levels perceived as comfortable for (1) ≥ 2 hours of uninterrupted wear and (2) ≥ 8 hours with 15 minute break periods every 2 hours and (b) Respirator relative humidity levels should be maintained at < 20% above base-line, on average, under low levels of exertion.

(22) (a) Respirator weight should be low enough, and distribution of weight sufficiently sym-metrical, to be comfortable and tolerable for (1) ≥ 2 hours of uninterrupted wear and (2) ≥ 8 hours with 15 minute break periods every 2 hours and (b) Respirator weight and mass distribution should be evaluated with a stan-dardized and validated clinical test for which performance criteria are developed.

(23) (a) Odor should be assessed with a standard-ized and validated clinical tool and (b) Perfor-mance criteria should be developed.

(24) (a) Respirators should be comfortable enough to be worn for 10 consecutive days under the following circumstances: (1) ≥ 2 hours of un-interrupted wear and (2) ≥ 8 hours with 15 minute break periods every 2 hours and (b) Perceived respirator discomfort during pro-longed wear should be assessed clinically using a validated and standardized test.

Healthcare System Policies and Practices

(25) Employer interviews, surveys and clinical tri-als should be conducted to determine respira-tor features that would lead employers to pur-chase one respirator over another.

(26) Employee interviews, surveys and clinical tri-als should be conducted to determine respi-rator features that would lead employees to choose one respirator over another.

(27) Patient and healthcare visitor interviews and surveys should be conducted to determine res-pirator features that would lead them to prefer one respirator over another.

(28) (a) Studies that estimate the costs and benefits of respirators across diverse settings should be completed and (b) Health economists and other fiscal experts should be recruited for par-ticipation in cost-effectiveness assessments.

An extensive research network makes the VA an ideal or-ganization to marshal the development of one or more new respirators to the U.S. marketplace in partnership with NIOSH and other Federal agencies. An extensive healthcare system in VA hospitals provides an excellent test bed for assessing and guiding prototype design. VA HCWs, who stand to receive the most benefit from a new respirator, are poised to assist with development. Together, this unique set of characteristics should put the VA in a position to demonstrate to Congress and the American taxpayer the benefits of improving respiratory protective equipment for HCWs. The same approach should lead to more cost-effective respirators that de-liver a net savings in the near future.


INTRODUCTION

The Better Respiratory Equipment using Advanced WG. These recommendations are based on clinical and Technologies for Healthcare Employees (Project laboratory evidence, when it is available, and rely on ex-BREATHE) Working Group (WG) is an interagency pert opinion when it is not. These 28 recommendations effort of the U.S. Federal government initiated by the may be regarded as (a) an action and research agenda for Department of Veterans Affairs (VA). The purpose of the Federal government, (b) a guide for the U.S. health Project BREATHE is to use a government-academic- care sector that identifies activities which might yield private partnership model to bring a new respirator for strong returns on their resource investment, and (c) a healthcare workers to the U.S. marketplace (Figure 1). research and development roadmap for the next genera-The aim of the WG (phase I of Project BREATHE) is tion of respirators used by the U.S. healthcare workforce. to develop a set of consensus recommendations that, if All 28 recommendations implemented simultaneously implemented, should improve the function and util- would be viewed as “ideal”. However, mass producing ity of respiratory protective equipment used by VA and a respirator in which all 28 stipulations were met, at a other healthcare workers (HCWs). cost viewed as reasonable by healthcare systems, might

not be plausible. The nation’s VA medical centers employ approximately 118,000 HCWs1 who wear and discard approximately The WG favors the development of a new respirator 1.6 million respirators per year2 at its 900+ outpatient class called a “B95” (Biological N95) which connotes clinics, 150+ hospitals and 136 nursing homes1. Provi- protection against biological particulates. This designa-sion of a safe workplace where HCWs can carry-out tion helps illuminate the differences between the new their occupational duties in a secure environment with- respirator type and the N95, R95 or P95 (the N, P out undue risk, during periods of routine operations or R classes of respirators). While the focus of Project and a variety of crises, is considered mission critical. BREATHE is on the VA system, it is understood that

these recommendations stand to influence the next gen-eration of respirators on a global scale. The primary purpose of this report is to articulate the

consensus recommendations of the Project BREATHE


BACKGROUND

Respirators have been used widely by U.S. HCWs since OSHA from enforcing its annual respirator fit-testing the early 1990s when tuberculosis (TB) saw a global re- standard15. This Act was subsequently abrogated.surgence3. The intended primary purpose of respiratory protective equipment in healthcare is to reduce the risk Discomfort and intolerance were frequent complaints of exposure in order to prevent the human-to-human of HCWs in Toronto who wore respiratory protection transmission of airborne infectious diseases4 via fine during the Severe Acute Respiratory Syndrome (SARS) particles (bioaerosols) that are emitted from the respira- crisis14. During the SARS outbreak, many Canadian tory tract of infected patients when coughing, sneezing public health organizations advised HCWs to use respi-or talking5. There may also be secondary benefits from ratory protection throughout the course of their work the use of respiratory protective equipment, such as pro- shifts, which often lasted 12 hours or longer16. Notwith-tection against blood and body fluid splashes or facial standing the ostensible protection provided by respira-protection from irritant substances6. In 1994, the Cen- tors, HCWs complained about headaches, facial heat ters for Disease Control and Prevention (CDC) recom- and pressure, shortness of breath, interference with oc-mended that HCWs caring for patients infected with cupational duties, among other problems associated with TB should don respiratory protection3. This approach, their use16,17-21. Respirator-associated discomfort and oc-which became the standard of care, was endorsed and cupational interference was viewed as a major limiting later bolstered via regulation by the Occupational Safety factor in work performance and, to an unknown extent, and Health Administration (OSHA)7. An ensuing pol- occupational absenteeism may have been related16,18,20. icy debate about the level of protection to be afforded Concerns have been raised about the same or similar HCWs during the course of their occupational duties events occurring in the U.S. during future epidemics14.led to a new respirator classification system (N, P, R no-menclature) that included a more precise identification of the filtration efficiency of each respirator type7 In 2006, the National Personal Protective Technology .

Laboratory (NPPTL) in the National Institute for Occu-pational Safety and Health (NIOSH) of the CDC made

As certain types of TB evolved into strains that were re- a request to the Institute of Medicine (IOM) for a re-sistant to treatment by many of the most common anti- view of personal protective equipment, with the explicit biotics8, HCWs became infected with TB with increas- purpose of recommending how to best protect HCWs ing frequency. In the late 1980s and early 1990s, several during an influenza pandemic14. In its report, Preparing HCWs died from occupational exposure to TB9. To for an Influenza Pandemic: Personal Protective Equipment enhance protection, HCWs began wearing respirators for Healthcare Workers, the IOM noted a conspicuous borrowed from other occupational sectors. Dust mist lack of evidence behind respirator protective measures, respirators (DMRs), akin to N95 respirators used cur- including minimal attention placed on the development rently) were used widely by the construction and manu- of equipment meeting the needs of HCWs. The IOM facturing industries7 to protect against the inhalation recommended revisiting elemental aspects of respirator of workplace dusts (particulates)4. DMRs were shown design and development, including a distinct attention to be effective in filtering simulant infectious disease to respirators tailored to the jobs performed by HCWs, particulates4, although a lack of clear clinical evidence and pursuing an evidence-based approach to equipment proving the effectiveness of respirators against airborne design, to the extent that this is possible (Figure 2). This infectious diseases led to controversy about the neces- report stressed the need for urgent action, emphasizing sity of this relatively expensive and intrusive protective that the next influenza pandemic could occur in the measure10. This controversy continues today and may be near future.partially responsible for the relative complacency11 and low compliance rates11,12,13 with respiratory protection guidelines among HCWs14. Further stirring controver-sy was an act of Congress (Wicker Act) that prevented


BUILDING THE “BREATHE TEAM”

VA leadership accepted the call to action by the IOM and directed the initial actions of the Project BREATHE Working Group to study ways to “Innovate and Strength-en Personal Protective Equipment Design [and] Testing“14 (Figure 3). An initial partnership was formed with the National Institute for Occupational Safety and Health (NIOSH) via a memorandum of understanding fol-lowed by outreach activities to all other relevant Federal agencies. A common agenda was reflected by productive collaboration among nine Federal agencies:

Project BREATHE — Participating Federal Agencies:(See Appendix A for a list of individual members)

• The National Personal Protective Technology Laboratory in the National Institute for Occupational Safety and Health in the Centers for Disease Control and Prevention (Department of Health and Human Services)

• Office for Infection Control, Division of Healthcare Quality Promotion in the Centers for Disease Control and Prevention (Department of Health and Human Services)

• National Center for HIV, STD and TB Prevention, Division of Healthcare Quality Promotion in the Centers for Disease Control and Prevention (Department of Health and Human Services)

• The U.S. Army Edgewood Chemical Biological Center (Department of Defense)

• The Occupational Safety and Health Administration (Department of Labor)

• The National Institute of Standards and Technology (Department of Commerce)

• The National Aeronautics and Space Administration

• Biomedical Advanced Research and Development Authority (Department of Health and Human Services)

• Office of Public Health and Environmental Hazards in the Veterans Health Administration (Department of Veterans Affairs)

The Food and Drug Administration (FDA) is notably absent because of legal stipulations raised by their Gen-eral Council; however, the FDA Center for Devices and Radiological Health reviewed this report before it was made available to the public.

Co-chaired by staff from the VA and the CDC, the WG had a broad range of expertise and experience, including (but not necessarily limited to):

• Pandemic and emergency preparedness;

• Infectious disease medicine;

• Infectious disease epidemiology;

• Infection control and prevention;

• Respirator and personal protective equipment policy and regulation;

• Respirator and materials science;

• Occupational and environmental medicine;

• Respirator physiology;

• Aerosol physics; and

• Biosecurity.

The focus of Project BREATHE was on the develop-ment of respiratory protection for HCWs who are em-ployed in hospitals and other clinical settings. It was not focused on the unique needs of paramedical personnel, such as ambulance or in-flight rescue medical teams or hazardous materials workers. In scope were respirators that protect against aerosolized infectious particulates (airborne pathogens) to which HCWs may be exposed, such as TB, measles and influenza. Protection against


agents that were perceived to have a high probability for use during terrorist events or biological warfare (Chem-ical, Biological, Radiological, Nuclear or Explosive events or CBNRE) were not specifically considered by the BREATHE WG. However, these agents were not in-tentionally excluded and may be viewed as included in the WG’s considerations to the extent that these agents may also cause naturally occurring infections.

The WG acknowledged that policy makers often seek to reduce risk of adverse events to zero. It should be noted that the WG believes this paradigm is not possible with respiratory protection. By nature, occupational activi-ties in healthcare carry an inherent risk of workplace-ac-

quired infection. Respiratory personal protective equip-ment is designed to be a last resort to infection control after various administrative and engineering methods are employed3. The aim of respirators is to limit the risk of HCW exposure, not to eliminate it. The extent to which risk is limited depends on numerous factors14 that are discussed in this report. Project BREATHE seeks to improve respirator tolerability, comfort, and other func-tional characteristics, while maintaining a level of pro-tection equivalent to, or greater than, current standards. If successful, changes that grow out of this report should increase compliance with respiratory protection guide-lines and standards among HCWs.


PROJECT BREATHE CONSENSUS DEVELOPMENT

Research for Project BREATHE began with the VA staff interviewing members of the WG to record problems with existing respiratory protective equipment and to record improvements recommended. Four key catego-ries of characteristics emerged:

• Respirators should perform their intended functions safely and effectively.

• Respirators should support, not interfere with, occupational activities.

• Respirators should be comfortable and tolerable for the duration of wear.

• Respiratory protective programs should comply with Federal standards and guidelines, state regulations, and local policies.

This framework was used to facilitate discussion among WG members. The team convened in Washington, DC in August 2008 to articulate and form a consen-sus about recommended features and performance re-quirements for the next generation of respirators. Only items that met team consensus were included in the fi-nal list of characteristics. The WG avoided making rec-ommendations about specific materials used in, or the final appearance of, future respirators. Instead, efforts were directed toward describing the desirable charac-teristics and identifying ways to assess the performance of respirators (using various laboratory-based and clini-

cal assessment methods) once these characteristics be-come incorporated. Throughout this report, the WG articulates its preference for clinical assessment methods (e.g., clinical trials; in situ measurements) over methods performed solely in the laboratory (e.g., surrogate bio-markers; correlates of physiologic response). However, in many instances clinical assessments were identified as impractical. In such cases, the WG favors the use of laboratory tools that have been validated against clini-cal outcomes. The recommendations included in this report have varying levels of urgency and importance; therefore, priority designations (1 through 5, with 1 be-ing the most important) were assigned to each recom-mendation based on consensus. Collectively, this set of recommendations constitutes an idealized view of the features included in next generation of respirators for HCWs.

Following the August 2008 meeting, this consensus re-port was drafted by the VA authors (LR and AB) and distributed to the WG for review, critique and modi-fication. The review was iterative until consensus was reached about textual changes. While the intended au-dience for this is the VA, the intent is to share these recommendations widely across the Federal government to propel the research that is needed among the agencies represented on the WG. A subsequent manuscript is planned for publication. The intention is to have future endeavors include discussions with private manufactur-ers about building one or more prototype respirators based on these recommendations.


WORKING GROUP CONSENSUS STATEMENTS ONSAFETY AND EFFECTIVENESS

The IOM report emphasized that in “this era of moving toward preparedness for a pandemic, it is important to examine the level of rigor employed to ensure that all forms of personal protective equipment are deemed to be safe and effective medical devices”.22 The BREATHE WG viewed safety and effectiveness as closely linked to comfort and tolerability. Even the most sophisticated respirators cannot be fully effective if they are not prop-erly worn. The respirators that emerge from Project BREATHE should be capable of performing effectively under a variety of circumstances, ranging from routine operations to bioterrorism.

Effectiveness of equipment used in the workplace is a characteristic that is often incorporated into policy and regulation. The utility and practical applicability of certain safety measures, such as the Assigned Protec-tion Factor (APF)4,29 or fit-testing24, have been studied extensively7,14,25. The intention of Project BREATHE is not make value judgments about current regulatory stipulations (Table 1), but instead to issue a list of con-sensus recommendations that align with, or build upon, current standards.

Consensus 1: Safety and Effectiveness

Objective: Respirators should function safely and effectively.

Recommendation: Respirators should meet current standards.

Priority Designation: 1

Currently, NIOSH certification is required for manu-facturers to place the NIOSH seal of approval on their products26. OSHA regulates respiratory protective equipment and places safety stipulations on the way it is used in all workplaces, including healthcare settings26. The WG agreed that in order for a respirator to work as designed, it needs to be used in the context of an OSHA compliant respiratory protection program (29 CFR 1910.134)28, including annual fit testing.

Clearance from the FDA is required for manufactur-ers to make claims about the protective effect against blood and body fluid splash protection fluid resistance, biocompatibility, and flammability. Medical claims can

only be made for devices sold in the U.S. that have re-ceived FDA clearance or approval29. Most respirator manufacturers do not seek such approval. The WG dis-cussed the possibility of including the FDA more for-mally in the approval process before respirators may be marketed, although a consensus was not reached and a recommendation was not issued.

Consensus 2: Self-Contamination

Objective: Respirators should be capable of being easily donned and doffed without causing self-contamination.

Recommendation: (a) A means should be developed to practically don and doff approved respirators without self-contamination and (b) A test should be developed, validated and standardized that assesses respirator contamination in a clinical environment.


Doffing and donning are among the most frequent ac-tivities associated with self-contamination30. Contami-nation of respirator surfaces with microorganisms may be sources of infection31, although the extent to which PPE contamination leads to transmission is unknown. Respirators that are designed to diminish self-contam-ination are desired. There is no standard way to mea-sure the likelihood of contamination; therefore, Fed-eral agencies (e.g., NIOSH and the National Institute of Standards and Technology (NIST)) should consider working together to develop an assessment tool. Simi-larly, manufacturers should propose means to practically assess self-contamination. The methods described by Casanova30 may serve as a starting point.

Consensus 3: Fomite Transmission

Objective: Respirators should not be a conduit for transmission of pathogens between persons.

Recommendation: (a) Designs should be utilized that prevent respirator-dependent transmission of infectious pathogens and (b) A test should be developed, validated and standardized that assesses respirator-dependent pathogen transmission in a clinical environment.



Because materials contaminated with microorganisms (fomites) may transmit infection from one person to another32, respirators should be constructed with mate-rials that minimize or eliminate this risk (e.g., through the use of an antimicrobial coating). Currently, two respirators approved by NIOSH contain antimicrobi-al components, however their efficacy at reducing the risks of handling after exposure to an infectious aerosol challenge is unknown. Manufacturers seeking approval for respirators incorporating antimicrobial technolo-gies need to satisfy requirements specified by NIOSH, FDA, and the Environmental Protection Agency (EPA) depending upon the specific claims being made33. As-sessment methods should be developed because there is no accepted standard. Manufacturers should propose ways to gauge fomite transmission in the healthcare workplace. One option might be the use of MS2 phage assays developed by NIOSH.34,35, 36

Consensus 4: Protection / Respirator Fit

Objective: Respirators should be inherently well-fitting and reduce HCWs particulate exposure to expected levels.

Recommendation: Respirators should be capable of providing a Simulated Workplace Protection Factor of 100 that is assessed using a standardized and validated measure (e.g., the NIOSH total inward leakage test) for a majority (ideally 90%) of healthcare workers wearing a “one-size-fits-all” (or as few sizes as possible) configuration.


There are numerous ways to measure the effectiveness of respirator use by HCWs. Arguably, the most important outcome is to reduce exposures leading to a decrease in infections among those who wear respirators compared to those who do not37. However, these types of clinical trials are very difficult and expensive to conduct38,39,40. More commonly, exposure to inert particulates in a lab-based environment serves as a surrogate for clinical out-come data. In the workplace, one measurement that has been validated in some occupations (but not healthcare) is the Workplace Protection Factor (WPF)41. A similar measure conducted in a laboratory setting under con-trolled conditions is the Simulated Workplace Protec-tion Factor (SWPF)25. Both WPF and SWPF values are calculated by comparing the number or concentration of particulates inside versus outside the filtered space. For many years, media technology has been advanced enough to confidently filter microorganisms42. Facial

seal is widely understood to be the primary source of respirator leakage14. Because definitive clinical trials have not been done to prove the level of protection necessary to prevent infections in HCWs, the APF hazard ratios4 (the inverse of the probability of exposure ratio, inside/outside) are assigned by OSHA somewhat arbitrarily.

One of the reasons some HCWs experience leaks around the facial seal with half-face respirators is because the shape does not approximate all of the curves of the face14. Some organizations purchase one or few respira-tor models for their workforces. In a setting with a large workforce, it would be highly unusual for one respirator to fit every worker — two models in different sizes are often required43, 44. If respirators were tailored to fit the facial characteristics of each user without manipulation, the likelihood of leaks might be much lower. Anthro-pometric tools45, auto-adjusting (“form fitting”) mate-rials,59 facial adhesives47 and novel polymers with high plasticity46 may facilitate development of a “one model fits most” approach.

Current NIOSH certification regulations do not have a fit test requirement for half-mask particulate air pu-rifying respirators. When the current NIOSH certifica-tion requirements were published in 1995 (see Federal Register Notice Vol. 60, No. 110 / Thursday June 8th, 1995 pages 30336-30404), it was felt that the fit test protocols in use at that time lacked sufficient validation to include as a requirement. NIOSH has proposed a new total inward leakage test to fill this gap48. This Proj-ect BREATHE requirement builds upon the proposed NIOSH requirement.

Consensus 5: Blood and Body Fluids

Objective: Respirators should serve as a barrier to protect the wearer from blood and body fluids.

Recommendation: Blood and body fluid penetration should be assessed with ASTM F 1862 - 07: Standard Test Method for Resistance of Surgical Mask to Penetration by Synthetic Blood.


While the primary purpose of respirators in healthcare is to filter airborne microorganisms and prevent occupa-tional illness4, some HCWs may also use them second-arily (and concurrently) as a facial shield against blood and body fluids29, such as during surgical procedures. Infection control precautions call for fluid and splash


protection whenever there is a possibility that such ex-posure may occur49. In contradistinction to respirators, surgical masks are designed to (a) protect the wearer from exposure to blood and body fluids and (b) protect others from the wearer who may expel infectious par-ticulates when coughing, sneezing or talking50.

Consensus 6: Reuse

Objective: Respirators should be capable of reuse. Recommendation: Respirators should be durable

enough for the respirator to provide a Simulated Workplace Protection Factor of > 100 after 50 brief worker-patient encounters, if necessary, during a crisis.


Use of disposable respirators has become a “standard operating procedure” for most U.S. hospitals22. Because most respirators are used for brief periods51 and discard-ed, there is little need for durable equipment that can be reused (e.g., multiple donnings). However, during a crisis in which respirators may be in short supply, respi-rators that are durable enough to be repeatedly reused may be necessary52. If a sufficient supply of respirators is not available, NIOSH and CDC have previously rec-ommended that healthcare facilities may consider reuse as long as the device has not been obviously soiled or damaged53. The WG proposes a definition of “reusable” to mean capable of maintaining or exceeding a SWPF > 100 for up to 50 interactions (each lasting ≤ 10 min-utes*) between the healthcare worker who is wearing the respirator and the patients s/he serves.

*Note: the maximum number of times a user could change his/her respirator over an 8 hour shift: 8 hours x 60 min-utes/50 changes = maximum HCW-patient interaction time (9.6 minutes) per respirator.

Consensus 7: Repeated Disinfection Durability

Objective: Respirators should be capable of being repeatedly decontaminated/disinfected during a crisis.

Recommendation: Respirators should be durable enough for the respirator to provide a Simulated Workplace Protection Factor of > 100 after 50 disinfections, each taking 60 seconds or less to complete.


Because most respirators are used for brief periods51 and discarded, there is little need for equipment that can be repeatedly disinfected. However, during a crisis in which respirator may be in short supply, respirators that are durable enough to be repeatedly decontaminat-ed (e.g., to render infectious materials on the respirator inactive and thus unable to act as a fomite) may be nec-essary. Current Federal regulations for certification of respiratory protective devices do not specify a minimum or maximum number of reuses. The only requirement identified in the body of the regulation is that “Mouth-pieces, hoods, helmets, and facepieces, except those em-ployed in single-use respirators, shall be constructed of materials that withstand repeated disinfection as recom-mended by the application in the instructions for use of the device”26. OSHA regulations54 indicate that respira-tor cleaning procedures “must ensure that the respira-tor is properly cleaned and disinfected in a manner that prevents damage to the respirator and does not cause harm to the user”. The WG proposes using a definition of “reusable” to mean capable of maintaining a SWPF > 100 for up to 50 decontamination/disinfection cy-cles. Ideally, respirators should be capable of disinfec-tion within 60 seconds. If this proves impossible, it may become necessary to assign each HCW two respirators to allow one to be disinfected while the other is worn. The method(s) of disinfection, including identification of disinfecting agent(s), should (1) be specified by the manufacturer and (2) approved by NIOSH as part of the user instructions, (3) be in compliance with the OSHA requirements (discussed above) for equivalent effective-ness, (4) not cause damage to the respirator, and (5) not harm the user. Mechanisms or tools of disinfection might include an alcohol swab, ultraviolet (UV) light, germicidal solution, microwave, or autoclave55. The WG favors an approach in which a standard method of determining “disinfection” evolves using a collaborative exchange of information among interested stakeholders, (e.g., manufacturers, NIOSH, OSHA, FDA, healthcare worker researchers) to avoid placing this burden solely on the manufacturer.

Consensus 8: Shelf-Life Durability

Objective: Respirators should be durable enough to tolerate a long shelf-life.

Recommendation: Respirators should be durable enough for the respirator to provide a Simulated Workplace Protection Factor of > 100 after being stored in air-conditioned space for at least 10


years at 21-23°C (69-73°F) and 45-55% relative humidity.


Many U.S. agencies’ recommendations call for stock-piling of respirators for use during a crisis8,50, 52,56. De-pending on the frequency of crisis events (an unknown figure), respirators may be in storage for a prolonged period, perhaps many years. Storage time can be limited by regularly using a portion of the stockpile for rou-tine operations and replenishing the stockpile with new items57. A specified shelf-life should be identified for all components of the respirator, including accessory items, such as filter cartridges, straps, and air hoses.

Consensus 9: Gauging Fit

Objective: HCWs should have a way to rapidly assess fit in the field.

Recommendation: Respirators should have a manufacturer-specified fit assessment technique (e.g., a user seal check) that is capable of detecting inadequate fit (Simulated Workplace Protection

Factor < 100) with at least 75% accuracy during work activities.

Priority Designation: Elastomeric (2); Filtering facepiece (5)

Conducting a brief assessment to determine whether a respirator fit is adequate may help workers become familiar with the type of fit that is most effective58. Al-though the benefit of respirator user seal checks might seem intuitive, recent studies have suggested that this practice may, in fact, not help identify adequate or in-adequate facial seal59,60,61. Regardless, user seal checks are a current mandatory requirement of an OSHA compli-ant respiratory protection program [Appendix B-1 to § 1910.134: User Seal Check Procedures]62.

Manufacturers and/or research organizations should develop new and effective ways of rapidly assessing fit in the workplace area of operations (“the field”), and should consider designing signals or indicators (e.g., colorimetric) that identify adequate fit for the user63.


WORKING GROUP CONSENSUS STATEMENTS ONSUPPORTING, NOT INTERFERING WITH, OCCUPATIONAL ACTIVITIES

One of the most frequent complaints about respirators in healthcare is their tendency to interfere with occu-pational activities16,18,20,22,64,65. This may occur in part because the respirators that are commonly used by U.S. HCWs were borrowed from other occupational sectors. Efforts should be made to tailor respiratory equipment to meet the unique needs of HCWs including commu-nications. The respirator should ideally not impair hear-ing, speech, or non-verbal communication. Another consideration is compatibility with other equipment used in the performance of healthcare delivery.

Consensus 10: Hearing Integrity

Objective: Respirators should not impede, and preferably improve, the wearer’s ability to hear.

Recommendation: (a) Specific word intelligibility tests should be developed, standardized and validated to more precisely measure the hearing accuracy of words in the healthcare setting and (b) Respirator wearers should achieve equivalent or higher scores on hearing acuity tests, on average, when wearing a respirator compared to no respirator.


The ambient noise in hospitals, especially intensive care units, has been shown to be excessive66. The ability to hear and to respond to emergency alarms or warn-ing devices may be impaired when wearing a respira-tor with a hood or helmet that covers the head67. The noise of a Powered Air-Purifying Respirator (PAPR) has been shown to be in excess of 70 decibels68. This level of noise may interfere with hearing integrity in a clini-cal setting69 and possibly lead to medical errors70. Hear-ing impairment, ranging from moderate to significant, was reported by 27% - 42% of HCWs (depending on the PAPR model used) during the SARS outbreak in 200319. Clearly hearing sounds during defibrillation has been shown to be very challenging when wearing a PAPR71. Approximately 1 in 10 words are heard in-correctly in the intensive care unit setting with typical ambient noise (about 60 decibels)72. The use of a PAPR has been shown to further diminish the intelligibility of words72. Respirators should not impede, and preferably improve, the wearer’s ability to hear. Measures routinely

used to assess hearing interference, such as the Modified Rhyme Test (MRT),73 lack specificity to the healthcare environment. The SPIN test74 is one option that uses whole sentences instead of single words.

Consensus 11: Speech Intelligibility

Objective: Respirators should not impede, and preferably improve, the ability of others to hear the wearer’s spoken words.

Recommendation: Respirator wearers should achieve equivalent or higher scores on speaking intelligibility tests, on average, when wearing a respirator compared to no respirator.


Many respirators decrease the intelligibility of words spoken by the respirator wearer72. A few half-face elas-tomeric respirators on the U.S. market are equipped with speech augmentation devices (e.g., “speaking mem-branes”). Such devices are only available in reusable res-pirators that are less commonly used than disposable fil-tering facepiece respirators by HCWs. They have been shown to have little if any effect on intelligibility72. New devices should be developed that increase word clarity spoken by the respirator wearer.

Consensus 12: Visual Field

Objective: Respirators should cause minimal or no obstruction of the wearer’s visual field.

Recommendation: (a) Visual fields should be assessed with a standardized and validated tool developed for use in the healthcare environment and (b) Healthcare visual field performance criteria should be developed for respirator wearers.


Respirators have been shown to obstruct the wearer’s visual field75. The inferior visual fields (looking down-ward) may be most affected by filtering facepiece respi-rators76,77. Although unproven, this type of interference could lead to occupational injuries35 or medical errors. Mitigating problems with eyewear fogging may be ben-eficial. The tests historically used to gauge visual field, such as the “apertometer,” specified in the European


standard (EN136:1998) and the NIOSH CBRN stan-dard78 are cumbersome and require test-administrator training. Obtaining the necessary visual field testing equipment can be difficult79. In addition to lab-based tools, visual field determinations should be, at least in part, conducted in clinical settings (“the field”) to en-sure data produced are applicable to the occupational setting of HCWs. Simple-to-use assessment tools that can be utilized in the field are needed for the healthcare environment.

Consensus 13: Facial Visualization

Objective: Respirators should be transparent, to the extent plausible and feasible, allowing visualization of the wearer’s face.

Recommendation: (a) Transparent respirator facepieces should be developed and, if possible, implemented and (b) Transparency should be assessed with an optical clearance test that is standardized and validated.


Respirators typically prevent visualization of the wearer’s mouth and a portion of the face. Improved visualiza-tion of the wearer’s lips might improve communication. Visualization of the face might also lower barriers to clinician-patient interactions and co-worker communi-cations.

Consensus 14: Equipment Compatibility

Objective: Respirators should not interfere with other equipment (e.g., stethoscope, otoscope) used in the healthcare environment.

Recommendation: (a) Respiratory protective equipment should be assessed for inter-equipment compatibility using a practical clinical test that should be developed, standardized, and validated and (b) Healthcare performance criteria for protective equipment compatibility should be developed.


During a high-risk intubation of a patient infected with multiple drug-resistant TB, the HCW performing the procedure might wear a gown, goggles or a face shield, shoe coverings, hair covering, and, possibly an N95 res-pirator underneath a PAPR80. The intubation process typically requires an unrestricted range of motion of both arms and the neck80. Numerous similar activities in healthcare require equipment compatibility. Care-ful planning is required to prevent respiratory protec-tive equipment from interfering with other equipment used in healthcare. Current NIOSH certification re-quirements26 for half-mask respirators only require that “half-mask facepieces shall not interfere with the fit of common industrial safety corrective spectacles.” The re-quirement recommended here would expand upon the NIOSH baseline requirement to include other items commonly used by HCWs.


WORKING GROUP CONSENSUS STATEMENTS ONCOMFORT AND TOLERABILITY

Lack of sufficient comfort and tolerability are among the most commonly cited problems with respirators mar-keted to healthcare workers. A growing interest to im-prove comfort and tolerance appears to be emerging14. As noted by the IOM and the National Research Coun-cil in a recent review of the NIOSH Personal Protective Technology program, “Understanding that comfort is fundamentally a safety issue is a necessary prerequisite to improvement of the materials, design and engineer-ing of PPT in such as way that critically important hu-man factors are taken into account.” When worn over prolonged work shifts, disposable model respirators are associated with facial pressure, irritation, and heat and reusable models are associated with communication and occupational interference65. Ideally respirators should be as comfortable to wear as a loose-fitting surgical mask.

Consensus 15: Breathing Resistance

Objective: The breathing resistance of a respirator should be tolerable.

Recommendation: (a) Respirators should have a level of breathing resistance that is low enough to be comfortable and tolerable for (1) ≥ 2 hours of uninterrupted wear and (2) ≥ 8 hours with 15 minute break periods every 2 hours and (b) Breathing resistance should be < 10 mm H2O pressure drop on average at 85 lpm.


Discomfort and intolerance have been two of the most significant barriers to routine51 and emergency use16,65 of respirators. HCWs are accustomed to wearing respira-tors for short durations51; however, during crises, they may be called on to wear protective equipment for a prolonged period22,65 (hours or days) with few excep-tions.

The airflow resistance across a respirator filter (“pres-sure drop”) at air flow speeds typical for human breath-ing81 is an important contributor to discomfort and intolerance.82,83 Although the pressure drop seen with commonly used respirators may not lead to excessive exertion in HCWs84, the psychometric sensation of breathing across filter material is associated with an uncomfortable feeling85. To circumvent this problem,

positive pressure respirators may be used. For settings in which the use of positive pressure is viewed as too cumbersome, costly or otherwise not possible, an inha-lation and exhalation mean pressure drop less than 10 mm H2O for each maneuver, at an airflow rate of 85 lpm, should be appropriate for assessment under cur-rent circumstances. Although this is a signification re-duction compared to the requirements in the current NIOSH standard (35 mm H2O with inhalation and 25 mm H2O with exhalation), recent unpublished research by NIOSH found that respirators currently in the U.S. strategic national stockpile have filter airflow resistance levels between 6.7 mm H2O and 9.4 mm H2O and thus may already meet this lower requirement57. A breath-ing pattern and airflow rate closer to human ventilation physiology (e.g., < 40-80 L/min)83 may be considered for use (and standardized) in the future. Additional re-search is needed to establish a quantitative relationship between filter airflow resistance and subjective comfort.

Consensus 16: Facial Irritation

Objective: Respirators should not cause facial irritation.

Recommendation: Facial irritation should be assessed using two standardized and validated tests: (a) A clinical assessment utilizing a pain or discomfort scale and (b) A lab-based sensitivity test, such as a transdermal water loss test or an animal skin sensitivity test.


Facial irritation, although typically mild, is often a con-tributing factor to respirator intolerance in HCWs.86,65 NIOSH respirator certification requirements (section 84.61) specify “respirator components which come into contact with the wearer’s skin should be made of nonir-ritating materials”. However, no specific test methods or performance requirements are identified in the stan-dard. There are a variety of factors associated with facial irritation, including skin inflammation due to contact with respirator material(s) or agents used to clean re-spiratory protective equipment. A portion of facial ir-ritation may be more precisely termed facial allergy or facial pressure — both of which are discussed as separate recommendations. To minimize this problem, respirator


material should be constructed with materials that are typically not irritating to facial skin and do not interact with skin care products. Eventually, it may be possible to use a sole lab-based test to determine facial irritation, once it is validated against clinical outcomes. Since this has not yet been done, two tests (one clinical and one lab) should be performed on each newly developed res-pirator model.

Consensus 17: Allergenicity

Objective: Respirators should not cause allergic reactions.

Recommendations: (a) Immune system stimulation should be assessed with a standardized and validated test and (b) Performance characteristics for allergenicity should be developed.


Occupational allergy is commonly cited as a reason for absenteeism87-93 or loss of work productivity93-96 although allergy to respiratory protective equipment is thought to be rare63,97 (unless the materials include latex). Allergic reactions to latex in the workplace can produce severe systemic manifestations including death98. Latex should therefore be avoided in personal protective equipment in favor of other polymers. There is no evidence indicat-ing that respirators currently marketed in the U.S. have not met this stipulation; however, the WG proposes that an absence of latex would be best articulated as a perfor-mance specification. A European biocompatibility test (e.g., ISO 10993) may be appropriate for use in the U.S. to demonstrate absence of reactivity.

Consensus 18: Facial Pressure

Objective: Facial pressure induced by respirators should cause minimal if any discomfort.

Recommendation: (a) Respirator facial pressure should be low enough to be comfortable and tolerable for (1) ≥ 2 hours of uninterrupted wear and (2) ≥ 8 hours with 15 minute break periods every 2 hours and (b) Facial pressure should be assessed using two standardized and validated tests:(a) a clinical assessment and a lab-based test. Priority Designation:

2

Pressure on the face is considered one of the more common reasons for intolerance to respirators among HCWs65,99. Facial heat, facial pressure, facial irritation,

and facial pain (discomfort) are considered individu-ally and discussed separately in this report. Facial heat is often associated with facial pressure because heat leads to sweating and a tight facial seal leads to moisture en-trapment inside the sealed respirator chamber. Simi-larly, facial pain is often associated with facial pressure because a tight facial seal can be painful69. To eliminate facial pressure, a loose-fitting respirator could be used. If a tight-fitting respirator is used, facial pressure can be minimized by achieving low particulate leakage us-ing mechanisms other than a tight facial seal (e.g., facial adhesive). Until new methods of assessing facial pressure are developed, both clinical and lab-based tests should be done on each newly developed respirator model. Eventually, it may be possible to use a sole lab-based test to determine facial pressure, once it is validated against clinical outcomes.

Consensus 19: Facial Heat

Objective: The internal environment of respirators should have a comfortable temperature.

Recommendation: (a) Respirators should cause a level of facial heat rise that is low enough to be comfortable for (1) ≥ 2 hours of uninterrupted wear and (2) ≥ 8 hours with 15 minute break periods every 2 hours and (b) Facial heat should not exceed a 7°F rise from baseline, on average, when the wearer is under low level exertion at 21-23°C (69-73°F) ambient temperature and 45-55% relative humidity.


Facial heat is often cited as a cause of respirator intol-erance99-102. It may be more common than previously acknowledged because higher inhaled air temperatures are associated with increased ventilation and shortness of breath102. The NPPTL is studying thermal imaging in an effort to better understand these processes80. A tem-perature gain less than 7°F has been associated with im-proved tolerance and is less likely to trigger a shortness-of-breath sensation99,102. Indoor ambient conditions that are typically considered comfortable are a temperature of 21-23°C (69-73°F) and a relative humidity of 45-55%.

Consensus 20: Air Exchange

Objective: Respirators should have adequate air exchange.

Recommendation: (a) Respirator CO2 dead space retention should be low enough to be comfortable


for (1) ≥ 2 hours of uninterrupted wear and (2) ≥ 8 hours with 15 minute break periods every 2 hours and (b) Respirator chamber CO2 levels at end-inhalation should be < 1%, on average.


Exchange of air from within the facial chamber (often called “dead space”) to the exterior of a half-face res-pirator serves several functions. It typically diminishes heat, moisture, exhaled gases (such as CO2) and partic-ulates103. Heat, moisture and particulates are discussed under separate recommendations. This section pertains to the effects of CO2.

During the normal respiratory cycle, exhalation into an air-tight space causes CO2 concentration to increase within an enclosed area80. Whether CO2 levels rise in a corresponding fashion depends on numerous factors, including the size of the closed space, the respiratory physiology of the user, the quality of the facial seal, the airflow pattern within a confined space and the length of time the respirator is worn without removal. The ex-tent to which respirator dead space CO2 causes a rise in serum CO2 is not completely understood and is being evaluated at this time80. Nevertheless, Japanese respira-tor certification calls for less than 1% inspiratory CO2, which may be viewed as an idealized performance fig-ure104. Dead space CO2 testing could be done in a hu-man subject trial or in a laboratory with an automated breathing and metabolic simulator (ABMS). The reli-ability of the ABMS tests needs to be examined for this application.

Exhalation valves, one-way valves that permit exhalation of CO2 but close during inhalation, are one method to decrease intra-mask CO2 levels*. However, it has been proposed that the use of an exhalation valve could permit an ill HCW to inadvertently expel infectious droplets or droplet nuclei through the valve toward a patient or coworker, causing disease transmission14. One approach that may help allay these concerns would be positioning the exhaust valves in such a way that the exhausted air is vented away from the anterior aspect of the respirator. Another option would be to filter the pertinent particles from the exhausted air as before it is expelled.

*Note: one reoccurring question has been whether permit-ting intra-mask CO2 to rise above 0.5% would violate OSHA standard 29CFR1910.1000 TABLE Z-1. The po-

sition of the WG was that it would not because OSHA standard 29CFR1910.1000 TABLE Z-1 pertains to the ambient environment, not respirators. The intra-mask dead space should not be considered ambient.

Consensus 21: Moisture Management

Objective: The internal environment of respirators should not be uncomfortably dry or humid.

Recommendation: (a) Respirator humidity should be maintained at levels perceived as comfortable for (1) ≥ 2 hours of uninterrupted wear and (2) ≥ 8 hours with 15 minute break periods every 2 hours and (b) Respirator relative humidity levels should be maintained at < 20% above baseline, on average, under low levels of exertion.


Intra-mask moisture (humidity) has not been well stud-ied. Laboratory and clinical studies should be conducted to determine the effect of moisture on comfort and tol-erability. Conventionally, relative humidity levels rang-ing from 30-60% should be relatively comfortable105. Although published data are limited, relative humidity can be expected to increase with increasing workload of the wearer99.

Consensus 22: Mass Features

Objective: Respirators should be positioned on the face in a fashion that is comfortable.

Recommendation: (a) Respirator weight should be low enough, and distribution of weight sufficiently symmetrical, to be comfortable and tolerable for (1) ≥ 2 hours of uninterrupted wear and (2) ≥ 8 hours with 15 minute break periods every 2 hours and (b) Respirator weight and mass distribution should be evaluated with a standardized and validated practical performance test for which performance criteria are developed


Heavy respirators are typically associated with low toler-ance and high discomfort106. Balancing a respirator can help decrease facial pressure points and prolong wear times107. Respirator designs that are as light as possible and have a symmetrical weight distribution should lend themselves to comfortable positioning. Weight balanc-ing tools, such as a “Center of Gravity” machine, should be used to assess weight and moment of inertia in the prototype development process.


Consensus 23: Odor

Objective: Respirators should be non-malodorous. Recommendation: (a) Odor should be assessed

with a standardized and validated clinical tool and (b) Performance criteria should be developed.


Malodorous respirators were cited as a problematic for healthcare workers during the SARS crisis, especial-ly among workers who were not accustomed to their use16. Respirators that have no odor, or at least are not mal-odorous, should be better tolerated. Clinical trials should be used to assess this subject. A laboratory sur-rogate measure may also be useful.

Consensus 24: Prolonged Tolerability

Objective: Respirators should be tolerated for a prolonged period during a crisis.

Recommendation: (a) Respirators should be comfortable enough to be worn for 10 consecutive days under the following circumstances: (1) ≥ 2 hours of uninterrupted wear and (2) ≥ 8 hours with 15 minute break periods every 2 hours and (b) Perceived respirator discomfort during prolonged wear should be assessed clinically using a validated and standardized test.


Respirators available in the U.S. market are often not tolerated well for more than 3-5 hours of wear, even with interposed break periods65, at least among wearers who use respirators infrequently or are accustomed to short duration use51. Although a respirator that is tolerated for prolonged periods is not always necessary, it may be-come important during a crisis16. Certain psychological characteristics of respirator wear may be related to the length of time worn, such as claustrophobia which is experienced in about 10% of respirator users69. Ways to diminish the likelihood of claustrophobia may include decreasing facial pressure and making smaller the size of the facial or head covering108. It should be expected that every respirator will be perceived as intolerable by some workers — no respirator has a perfect tolerance record. While tolerance duration of one work shift (approxi-mately 8 hours) is an essential requirement, (as identi-fied in other recommendations), 10 days of consecutive use for 8 hours per day is a secondary objective, such that the respirator may be comfortably used during a prolonged disease outbreak.


Although policies at most U.S. medical centers are writ-ten to be in compliance with national, state and local regulatory stipulations, it is widely acknowledged that many institutions do not put the full extent of their pol-icies into practice. The scope of this discrepancy is un-known, but conventional wisdom holds that it involves medical institutions across the U.S. Incomplete compli-ance probably increases the risk of healthcare associated infections109 and may lead HCWs to believe the policies are unnecessary, frivolous or ill-advised11-13.

Perhaps one of the most important shortcomings of res-pirator science is a lack of clinical evidence demonstrat-ing to what extent respirators diminish the occurrence of infectious diseases. If it were shown that respirators, in fact, significantly diminish the likelihood of illness or death among HCWs, it is probable that fewer work-ers would be non-compliant and still fewer would fa-vor their removal from healthcare facilities altogether. Therefore, the WG believes that clinical trials should be conducted to improve understanding about the ef-fectiveness of respirators and respiratory protection pro-grams in the healthcare setting.

Consensus 25: Employer Desirability

Objective: Respirators should be viewed by employers as important and desirable components of their protective equipment.

Recommendation: Employer interviews, surveys and clinical trials should be conducted to determine respirator features that would lead employers to purchase one respirator over another.


The types of respirators purchased for use in medical centers are typically dependent on the opinion of lead-ership toward respiratory protection (RP) programs. Anecdotally, some employers look to purchase the least expensive respirator model for their RP programs. A cultural change needs to occur such that employers see respirators as an investment in the health and safety of their HCWs and patients. Such a change may be, in part, predicated on clinical trials demonstrating cost ef-fectiveness and cost/benefit of respiratory protection. It may also require qualitative research with healthcare

leaders to assess attitudes about RP policies and prac-tices.

Consensus 26: Employee Desirability

Objective: Respirators should be viewed by employees as important and desirable components of their protective equipment.

Recommendation: Employee interviews, surveys and clinical trials should be conducted to determine respirator features that would lead employees to choose one respirator over another.


Most HCWs do not like to wear respirators14,16,110. More comfortable and tolerable respirators may help mitigate this problem110. For some HCWs, respirators and per-sonal protective equipment help them feel “safe” in an uncertain environment11,12; however, compliance re-mains poor14. Convincing HCWs that certain respira-tors are more desirable than others may be predicated on clinical trials that demonstrate effectiveness37. Modi-fications to respirators requested by HCWs may also play an important role14.

Consensus 27: Patient Desirability

Objective: Respirators should be viewed by patients/visitors as important components of HCW protective equipment.

Recommendation: Patient and healthcare visitor interviews and surveys should be conducted to determine respirator features that would lead them to prefer one respirator over another.


The views of patients, family members and other visi-tors toward respirator use have not been well studied. However, their views may influence the use and pur-chase of respirators. Some may be comforted to learn that HCWs serving them and their family members are taking precautions. Still, reports of concern among patients and workers have occurred when HCWs don respirators that have an unusual appearance74,109,111,112. Respirators should facilitate the HCW-patient relation-ship, not interfere with it.

WORKING GROUP CONSENSUS STATEMENTS ONHEALTHCARE SYSTEM POLICIES AND PRACTICES


Consensus 28: Cost Effective for Employers

Objective: Respirator usage should be cost-effective.

Recommendation: (a) Studies that estimate the costs and benefits of respirators across diverse settings should be completed and (b) Health economists and other fiscal experts should be recruited for participation in cost-effectiveness assessments.


Although the purpose of project BREATHE is to issue recommendations about the preferred characteristics of respirators, it is important to acknowledge and discuss the costs of respirators to manufacturers and employers. The cost of respirators transcends all aspects of respi-rator research, development, production, and practice. Among the more important aspects of cost may be the manufacturer’s perceived return on investment prior to researching potential technologies and the employer’s return on investment in terms of diminishing occupa-tional illnesses. Further, all aspects of cost are inter-re-lated such that modification of one variable may affect other cost assumptions and outcomes.

Employers are continually faced with decisions on how to allocate resources subject to their budget constraints. Respiratory protection programs compete with many

other production inputs in this allocation of resources. If respirators are viewed as an unfunded mandate rather than imperative of safety, then organizations need to be convinced that respirators are essential.

Additional work is needed to link the benefits of respi-rator usage with the costs. Few cost-benefit studies ex-ist. To date, studies primarily have focused solely on the costs of respirators and respiratory protection programs. One study estimated the median hospital compliance costs related to TB as required by the CDC and OSHA as being $83,900 for respirators and $17,187 for res-pirator fit-testing programs113. However, these findings may not be generalizable as the study was conducted in only five hospitals.

OSHA conducted an economic analysis of respiratory protective equipment as required by its rulemaking process113. Annual incremental costs across all indus-tries were estimated to be about $111 million with 90 percent of those costs allocated toward fit testing ($67 million) and training ($36 million). For the health ser-vices industry, OSHA estimated that the incremental compliance costs constituted 0.01 % of sales and 0.14 % of profit. OSHA’s study did discuss the possible ben-efits of respirators, such as averted illness, injuries, and death, but did not monetize those benefits or calculate cost benefit ratios.


CONCLUSION AND NEXT STEPS

The Project BREATHE WG was convened to make rec-ommendations on behalf of the U.S. Federal Govern-ment to the VA about the characteristics that should be included in the next generation of respirators for health-care workers. Table 2, A Comparison of Established Federal Agency Specifications and the B95 BREATHE Recommendations, provides a summary of the 28 fea-tures and performance characteristics articulated in this report, in the context of current regulations, guidelines and standards. Publication of this document completes Phase I of Project BREATHE (Figure 1). To avoid con-fusion, it should be noted that several new respirator criteria have also been discussed by regulatory agencies and other stakeholders (Table 3) that were developed using an entirely different process than was used by the Project BREATHE WG.

Although these respirator characteristics were parsed into 28 recommendations, in reality many overlap and influence each other. Some are competing objectives. The WG also acknowledges that this set of recommen-dations offers an idealized view of the respirator charac-teristics to be included in the next generation of respi-rators for HCWs. It may not be possible to develop a prototype in which all or most of these recommenda-tions are implemented.

Because these recommendations cover a broad range of design and performance characteristics, and many re-quire additional research, it is important that they be shared with manufacturers, academia, and the private sector healthcare community. The development of B95 respirator prototypes may be facilitated via parterships, such as joint governmental and private sector action. Therefore, the WG encourages the VA to publish these

recommendations in a peer-reviewed journal to make them widely available.

Given a variety of competing objectives in these recom-mendations, the WG favors a “hybrid” respirator that is disposable under routine conditions but could be reused if necessary during a crisis. Such models that are scalable in complexity are viewed with optimism. This might in-clude a lightweight, relatively simple model for routine use with features (e.g., a powered air supply) that can be temporarily added when necessary.

This report represents an opportunity for VA to shape national policy and establish a strong culture of safety in its institutions. To be successful, however, multiple performance tests need to be developed and validated. Clinical effectiveness studies should be initiated. Dem-onstration projects should begin soon, possibly using a subset of VA medical centers as a test-bed.

Finally, the WG invites the FDA to join in this effort to the extent that it does not conflict with their regulatory mission. FDA’s participation is needed to help ensure that preventive health claims are substantiated with sci-entific evidence, similar to other products under FDA purview.

Improving respirator tolerability and functionality should lead to wider acceptance of respirators as a means of protection for VA and other HCWs. This report has outlined several steps towards the next phase in the evo-lution of respirators. For the recommendations in this report to result in meaningful improvements, continu-ous study and refinement will be essential.


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FIGURE 1: PHASES OF PROJECT BREATHE

• Phase I: Formation of a Federal governmental interagency working group that will issue a consensus statement about the types of respirator characteristics believed to be ideal for the healthcare workforce. The consensus statement will include recommendations for “evidence-based performance requirements (prescriptive standards) for PPE” and to “establish measures to assess and compare the effectiveness of PPE.”54

• Phase II: Developing one or more respirator prototypes that utilize some or all of the features recommended in Phase I. This phase would occur in collaboration with the private sector and academia in a “coordinate[d] effort”54 Testing the prototype(s) in healthcare workers prior to larger-scale production will “increase

research on the design and engineering of the next generation of PPE.”54

• Phase III: Laboratory and field testing of the prototype respirator(s) in an effort to ensure it meets performance requirements and “increase research on the design and engineering of the next generation of PPE”54 and “strengthen pre-market testing.”54

• Phase IV: Making the new respirator(s) available to the wider healthcare workforce to “strengthen post-market evaluation”54 using post-development research efforts, aiming to further improve the new design.


FIGURE 2: INSTITUTE OF MEDICINE RECOMMENDATIONS FOR EVIDENCE-BASED PERFORMANCE MEASURES

s

Evidence-Based Performance Requirements

Functionality• Protect against

influenza virus• Guard against contact

with contaminated fluids and aerosols

Usability• Maintain biomechanical

efficiency and sense of touch and feel

• Odor-free• Hypoallergenic• Accommodate wide

range of users (face andbody profiles)

• Compatibility across various elements of the PPE ensemble and with other equipment (e.g., stethoscope)

• Non-startling to patientand families

• Facilitate communication with others (verbal, facial)

Comfort and wearability

• Comfortable — no skin irritation or pressure points

• Prolonged use without discomfort

• Breathable — air permeable

• Moisture absorbent — wickability

• Low bulk and weight• Dimensional stability• Easy to put on and take

off (don and doff)

Maintenanceand Reuse

• Easy to decontaminate and discard disposable elements

• Easy to clean and replace parts in reusable PPE

Cost• Product cost• Total life-cycle cost• Minimal environmental

impact

Aesthetics• Variety of styles and

colors• Customizable

Durability• Adequate wear life• Strength — tear, tensile,

burst• Abrasion resistance• Corrosion resistance

*Reproduced with permission from the National Academies Press


FIGURE 3: INSTITUTE OF MEDICINE RECOMMENDATIONS* TO INNOVATE AND STRENGTHEN PPE** DESIGN, TESTING AND CERTIFICATION

• Adopt a Systems Approach to the Design and Engineering of the Next Generation of PPE

• Coordinate Efforts and Expand Resources for Research and Approval of PPE

• Ensure Balance and Transparency of Standards-Setting Processes

• Define Evidence-Based Performance Requirements (Prescriptive Standards) for PPE

• Establish Measures to Assess and Compare the Effectiveness of PPE

• Increase Research on the Design and Engineering of the Next Generation of PPE

• Strengthen Pre-market Testing of PPE for Healthcare Workers

• Strengthen Post-market Evaluation of PPE for Healthcare Workers

*Adapted from “Overview of the Report Recommendations” Box S-1 in Preparing for an InfluenzaPandemic: Personal Protective Equipment for Healthcare Workers

**PPE: Personal Protective Equipment

PROJECT B.R.E.A.T.H

.E. REPORT • 33

X

X

X

TABLE 1: CURRENT RESPIRATOR PERFORMANCE REQUIREMENTS ISSUED BY PERTINENT U.S. GOVERNMENTAL AGENCIES AND OVERSIGHT ORGANIZATIONS

Feature/Characteristic

AgencyCDC/NIOSH/ NPPTL †FDA OSHA VA ASTM ISO


Safety and Effectiveness X

Meets FDA recommendations & NIOSH certified N95 Respirator certification standards

29 CFR Ch. XVII 1910.134 (d) (3) (i) The employer shall provide a respirator that is adequate to protect the health of the employee and ensure compliance with all other OSHA statutory and regulatory requirements, under routine and reasonably foreseeable emergency situations.

3All respirators used will be certified by the National In-stitute for Occupational Safety and Health (NIOSH) and be used in accordance with the terms of that certification.

X

Self-Contamination X X X X X

FomiteTransmission X X X X X

Protection/Respirator Fit

5Respirator Selection Logic 2004 (Table 1): Assigned Protec-tion Factor > 10; can only be achieved if the respirator is qualitatively or quantitatively fit tested on individual work-ers. 442 CFR Ch. 1 84.175 (a) Half-mask facepieces and full facepieces shall be designed and constructed to fit persons with various facial shapes and sizes either: (1) By providing more than one facepiece size; or (2) By providing one facepiece size which will fit varying facial shapes and sizes.

X

29 CFR Ch. XVII 1910.134 (d) (A) Table 1: APF = 10 for Air-Purifying Respirator, includ-ing filtering facepieces, and half masks with elastomeric facepieces.

X

12ASTM F2100-07 - Standard specification for performance of materials used in medical face masks.

X

Abbreviations

AIHA - American Industrial Hygiene AssociationANSI - American National Standards InstituteASTM - American Society for Testing andMaterialsCDC - Centers for Disease Control and PreventionFDA - Food and Drug AdministrationISO - International Organization for StandardizationNIOSH - National Institute for Occupational Safety and HealthNIST - National Institute of Standards andTechnologyNPPTL - National Personal Protective Technology LaboratoryOSHA - Occupational Safety and Health AdministrationVA - Department of Veterans Affairs

References

1OSHA Standard 29 CFR Ch. XVII 1910.134 8Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification 2VA Tuberculosis Exposure Control Plan, August 14, 2008 [510(k)] Submissions, March 5, 20043VA Respiratory Protection Program, October 26, 2006 9FDA - About Personal Protective Equipment: www.fda.gov/cdrh/ppe/about.html4NIOSH 42 CFR Ch. 1 Part 84 10www.aiha.org/Content/InsideAIHA/Standards/z88.htm5Respirator Selection Logic for particulate respirators 2004: http://www.cdc. 11www.iso.orggov/niosh/docs/2005-100/ 12www.astm.org6NIOSH Guide to the Selection and Use of Particulate Respirators - Certified †FDA regulations apply to surgical masks and surgical N95 masks. Under 42 CFR 84, January 1996 FDA has purview over respirators about which medical claims are made.7MMWR, Guidelines for Preventing the Transmission of Mycobacterium tuberculo-sis in Health-Care Settings, 2005

34 • P

ROJECT B.R.E.A.T.H.E. R

EPORT



Blood & Body Fluids

7Combination product surgical mask/N95 disposable respirators (respirator portion certified by CDC/NIOSH and surgical mask portion listed by FDA) are avail-able that provide both respira-tory protection and bloodborne pathogen protection.

8Recommend that fluid resis-tance of device be evaluated using the following standard: ASTM F 1862: Standard Test Method for Resistance of Surgical Mask to Penetration by Synthetic Blood.

X X

12ASTM F2100-07 - Standard specification for performance of materials used in medical face masks; ASTM F-1862-07 - Standard Test Method for Resis-tance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Protection of Fixed Volume at a Known Velocity).

11ISO 22609: 2004 Cloth-ing for protection against infectious agents - medical face masks - test method for resistance against penetration by synthetic blood.

Reuse

6All filters should be replaced whenever they are damaged, soiled, or causing noticeably increased breathing resistance (e.g., causing discomfort to the wearer). N-series filters would also be subject only to considerations of hygiene, dam-age, and increased breathing resistance. 7Respirators with replaceable filters are reusable, and a respirator classified as disposable can be reused by the same HCW as long as it remains functional and is used in ac-cordance with local infection-control procedures.

9Do not reuse personal protec-tive equipment. Almost all personal protective equipment used in patient care is dispos-able and is designed to be used one time for contact with one patient.

X

2Disposable respirators may be reused for up to two weeks or until the mask is soiled, or no longer maintains its struc-tural or functional integrity as evidenced by inspection or failure of the fit check. Disposable N-95 masks should be discarded at the end of the work shift or when soiled or no longer maintains its struc-tural or functional integrity.

X

RepeatedDisinfectionDurability

7Disposable respirators should be discarded according to local regulations.

9There is no proper way to wash or disinfect disposable personal protective equipment. Dispose of the equipment carefully after each patient use or if the equipment becomes soiled.

29 CFR Ch. XVII 1910.134 (h) (1) & Appendix B-2: Employer shall ensure that respirators are cleaned and disinfected using the procedures in Ap-pendix B-2; the importance of thorough rinsing cannot be overemphasized. Detergents or disinfectants that dry on face-pieces may result in dermatitis. In addition, some disinfectants may cause deterioration of rub-ber or corrosion of metal parts if not completely removed.

3Reusable respirators are to be regularly cleaned and disinfected at the designated respirator cleaning station located in each workspace. Respirators issued for the exclusive use of an employee shall be cleaned as often as necessary; however, specific cleaning frequencies may be developed by the Program Administrator. Disposable res-pirators have no user service-able parts and a new one must be obtained when the old one is discarded. No components will be replaced or repairs made for reusable devices beyond those recommended by the manufacturer.

X

X

X

Abbreviations


References


PROJECT B.R.E.A.T.H

.E. REPORT • 35



Shelf-lifeDurability X X X X X

Gauging Fit

Elastomeric

6In addition to fit-testing, your respirator manufacturer has recommended fit-checking procedures that should be followed by the user each time the respirator is worn. For elas-tomeric respirators that have a chemical cartridge capability in addition to particullate filers 84.205 Facepiece test; minimum requirements requires an isoamyl acetate fit test on “persons having a varying facial of shapes and sizes

X

29 CFR Ch. XVII 1910.134 (g) (B) (iii) - For all tight-fitting respirators, the employer shall ensure that employees perform a user seal check each time they put on the respirator using the procedures in Appendix B-1 or procedures recommended by the respirator manufacturer that the employer demonstrates are as effective as those in Appendix B-1 of this section..

3All employees shall conduct user seal checks each time they wear their respirator. Employees shall use either positive or negative pressure check (depending on which test works best for them) specified in OSHA’s Respira-tory Protection Standard.

X

FilteringFacepiece

6In addition to fit-testing, your respirator manufacturer has recommended fit-checking procedures that should be fol-lowed by the user each time the respirator is worn.

X

29 CFR Ch. XVII 1910.134 (g) (B) (iii) - For all tight-fitting respirators, the employer shall ensure that employees perform a user seal check each time they put on the respirator using the procedures in Appendix B-1 or procedures recommended by the respirator manufacturer that the employer demonstrates are as effective as those in Appendix B-1 of this section.

3All employees shall conduct user seal checks each time they wear their respirator. Employees shall use either positive or negative pressure check (depending on which test works best for them) specified in OSHA’s Respira-tory Protection Standard.

X

Occupational Interference

Hearing Integrity X X X X X X

SpeechIntelligibility X X X X X

Visual Field

442 CFR Ch. 1 84.176 Face-pieces, hoods, and helmets shall be designed and constructed to provide adequate vision which is not distorted by the eyepieces.

X X X X

X

X

X

X

X

Abbreviations


References


36 • P


EPORT



FacialVisualization X X X X X

EquipmentCompatibility

442 CFR Ch. 1 84.175 (e) & (f) Facepieces, hoods, and helmets shall be designed to prevent eyepiece fogging. (f) Half-mask facepieces shall not interfere with the fit of common industrial safety corrective spectacles.

X

29 CFR Ch. XVII 1910.134 (g) (1) (B) (ii) If an employee wears corrective glasses or goggles or other personal protective equipment, the employer shall ensure that such equipment is worn in a manner that does not interfere with the seal of the facepiece to the face of the user.

X X

Comfort& Tolerability

Breathing Resis-tance

442 CFR Ch. 1 84.180 (b) The resistances for particulate respirators upon initial inhala-tion shall not exceed 35 mm water column height pressure and upon initial exhalation shall not exceed 25 mm water column height pressure.

8Recommend differential pres-sure be evaluated for surgical masks that are not NIOSH certified N95 Respirators; surgical masks that are NIOSH certified N95 Respirators must meet NIOSH N95 requirements for differential pressure.

X X

12ASTM F2100-07 - Standard specification for performance of materials used in medical face masks.

11ISO/TS 16976-1: 2007 Hu-man factors Part 1: Metabolic rates and respiratory flow rates.

Facial Irritation

442 CFR Ch. 1 84.61 (b) Respira-tor components which come in to contact with the wearer’s skin shall be made of nonirritating materials.

8Recommended that biocom-patibility of materials be evaluated as described in the standard ISO 10993, “Bio-logical Evaluation of Medical Devices Part I: Evaluation and Testing.”

X X X

11ISO 10993-1:2003 Biologi-cal evaluation of medical de-vices --Part 1: Evaluation and testing; ISO 10993-10:2002 Biological evaluation of medi-cal devices --Part 10: Tests for irritation and delayed-type hypersensitivity; ISO 10993-12:2007 Biological evaluation of medical devices--Part 12: Sample preparation and refer-ence materials; ISO 10993-18:2005 Biological evaluation of medical devices--Part 18: Chemical characterization of materials.

X

X

Abbreviations


References

l

1OSHA Standard 29 CFR Ch. XVII 1910.134 8Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification 2VA Tuberculosis Exposure Control Plan, August 14, 2008 [510(k)] Submissions, March 5, 20043VA Respiratory Protection Program, October 26, 2006 9FDA - About Personal Protective Equipment: www.fda.gov/cdrh/ppe/about.htm4NIOSH 42 CFR Ch. 1 Part 84 10www.aiha.org/Content/InsideAIHA/Standards/z88.htm5Respirator Selection Logic for particulate respirators 2004: http://www.cdc. 11www.iso.orggov/niosh/docs/2005-100/ 12www.astm.org6NIOSH Guide to the Selection and Use of Particulate Respirators - Certified †FDA regulations apply to surgical masks and surgical N95 masks. Under 42 CFR 84, January 1996 FDA has purview over respirators about which medical claims are made.7MMWR, Guidelines for Preventing the Transmission of Mycobacterium tuberculo-sis in Health-Care Settings, 2005

PROJECT B.R.E.A.T.H

.E. REPORT • 37



Allergenicity

42 CFR 84.62 (a0 The compo-nent parts of each respirator shall be: (1) designed, con-structed and fitted to insure against creation of any hazard to the wearer.

8Recommended that biocom-patibility of materials be evaluated as described in the standard ISO 10993, “Bio-logical Evaluation of Medical Devices Part I: Evaluation and Testing.”

X X X

11ISO 10993-1:2003 Biologi-cal evaluation of medical de-vices --Part 1: Evaluation and testing; ISO 10993-10:2002 Biological evaluation of medi-cal devices --Part 10: Tests for irritation and delayed-type hypersensitivity; ISO 10993-12:2007 Biological evaluation of medical devices--Part 12: Sample preparation and refer-ence materials; ISO 10993-18:2005 Biological evaluation of medical devices--Part 18: Chemical characterization of materials.

Facial Pressure

442 CFR Ch. 1 84.178 (a) All facepieces shall be equipped with head harnesses designed and constructed to provide adequate tension during use and an even distribution of pressure over the entire area in contact with the face; 442 CFR Ch. 1 84.178 (b) Facepiece head har-nesses, except those employed on single-use respirators, shall be adjustable and replaceable. Head harness is an undefined term in the regulation. NIOSH current policy is to accept applications with non-tradi-tional facepiece mounting ofr “single-use respirators “ using a quantitative particulate fit test to evaluate the effectiveness of the facepiece attachment.March 10 2009 Letter to All Manufacturers http://www.cdc.gov/niosh/npptl/usernotices/pdfs/Novel.pdf

X

129 CFR Ch. XVII 1910.134 Appendix A Part I (A) (6) Assessment of comfort shall include a review of the follow-ing points with the test subject and allowing the test subject adequate time to determine the comfort of the respirator: (a) position of the mask on the nose & (d) position of mask on face and cheeks; 129 CFR Ch. XVII 1910.134 Appendix A Part I (A) (7) The following criteria shall be used to help determine the adequacy of the respirator fit: (b) adequate strap tension, not overly tightened.

X X X

Abbreviations


References


38 • P


EPORT



Facial Heat X

8Recommend differential pres-sure be evaluated for surgical masks that are not NIOSH certified N95 Respirators; surgical masks that are NIOSH certified N95 respirators must meet NIOSH N95 requirements for differential pressure.

X X X11ISO/TS 16976-1: 2007 Hu-man factors Part 1: Metabolic rates and respiratory flow rates.

Air Exchange X

8Recommend differential pres-sure be evaluated for surgical masks that are not NIOSH certified N95 Respirators; surgical masks that are NIOSH certified N95 respirators must meet NIOSH N95 requirements for differential pressure.

X X X11ISO/TS 16976-1: 2007 Hu-man factors Part 1: Metabolic rates and respiratory flow rates.

Moisture Manage-ment

42 CFR 84.175 (e) facepieces, hoods and helmets shall be designed to prevent eyepiece fogging

8Recommend differential pres-sure be evaluated for surgical masks that are not NIOSH certified N95 respirators; surgical masks that are NIOSH certified N95 respirators must meet NIOSH N95 requirements for differential pressure.

X X X

Mass Features X X X X X X

Odor X X X X X X

ProlongedTolerability X X X X X

Healthcare System Policies &

Practices

EmployerDesirability X X X X X

EmployeeDesirability X X X X X

PatientDesirability X X X X X

Cost Effective for Employers X X X X X

Abbreviations


References


X

X

X

X

X

X


TABLE 2: COMPARISON OF CURRENT U.S. GOVERNMENTAL AGENCIES’ AND OVERSIGHT ORGANIZATIONS’RESPIRATOR PERFORMANCE CHARACTERISTICS WITH BREATHE RECOMMENDATIONS

Current Agency Respirator Characteristics BREATHE “B95” Recommendations BWG Priority Value




129 CFR Ch. XVII 1910.134 (d) (3) (i) The employer shall provide a respirator that is adequate to protect the health of the employee and ensure compliance with all other OSHA statutory and regulatory requirements, under routine and reasonably foreseeable emergency situations; 3All respirators used will be certifi ed by (NIOSH) and be used in accordance with the terms of that certifi cation; 9Meets FDA recommendations & NIOSH certifi ed N95 Respirator certifi cation standards.

Respirators should meet current standards. 1

Self-Contamination X

(a) A means should be developed to practically don and doff approved respirators without self-contamination and (b) A test should be developed, validated & standardized, that assesses respirator contamination in a clinical environment.

1

Fomite Transmission X

(a) Designs should be utilized that prevent respirator-dependent transmission of infectious pathogens and (b) A test should be developed, validated & standardized that assesses respirator-dependent pathogen transmission in a clinical environment.

1

Protection/Respirator Fit

129 CFR Ch. XVII 1910.134 (d) (A) Table 1: APF = 10 for Air-Purifying Respirator, including fi ltering facepieces, and half masks with elastomeric facepieces; 5Respirator Selection Logic 2004 (Table 1): Assigned Protection Factor > 10; can only be achieved if the respirator is qualitatively or quantitatively fi t tested on individual workers. 442 CFR Ch. 1 84.175 (a) Half-mask facepieces and full

Respirators (available in one or few sizes) used in the healthcare workplace should be capable of providing a Simulated Workplace Protection Factor of 100 that is assessed using a standardized and validated measure (e.g., the NIOSH total inward

1

facepieces shall be designed and constructed to fi t persons with various facial shapes and sizes either: (1) By providing more than one facepiece size; or (2) By providing one facepiece size which will fi t varying facial shapes and sizes.

leakage test) for a majority (90%) of healthcare workers.

Blood & Body Fluids

8Recommend that fl uid resistance of device be evaluated using the following standard: ASTM F 1862: Standard Test Method for Resistance of Surgical Mask to Penetration by Synthetic Blood; 7Combination product surgical mask/N95 disposable respirators (respirator portion certifi ed by CDC/NIOSH and surgical mask portion listed by FDA) are available that provide both respiratory protection and bloodborne pathogen protection.

Blood and body fl uid penetration should be assessed with ASTM F 1862-07: Standard Test Method for Resistance of Surgical Mask to Penetration by Synthetic Blood.

3

References & Abbreviations

1OSHA Standard 29 CFR Ch. XVII 1910.1342VA Tuberculosis Exposure Control Plan, August 14, 20083VA Respiratory Protection Program, October 26, 20064NIOSH 42 CFR Ch. 1 Part 845Respirator Selection Logic for particulate respirators 2004: http://www.cdc.gov/niosh/docs/2005-100/6NIOSH Guide to the Selection and Use of Particulate Respirators - Certifi ed Under 42 CFR 84, January 19967MMWR, Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005

8Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notifi cation [510(k)] Submissions, March 5, 20049FDA - About Personal Protective Equipment: www.fda.gov/cdrh/ppe/about.html10www.aiha.org/Content/InsideAIHA/Standards/z88.htm11www.iso.org12www.astm.org13BWG: BREATHE Working Group




Reuse

7Respirators with replaceable fi lters are reusable, and a respirator classifi ed as disposable can be reused by the same HCW as long as it remains functional and is used in accordance with local infection-control procedures; 9Do not reuse personal protective equipment. Almost all personal protective equipment used in patient care is disposable and is designed to be used one time for contact with one patient.

Respirators should be durable enough for the respirator to provide a Simulated Workplace Protection Factor of >100 after 50 brief worker-patient encounters, if necessary, during a crisis.

1

Repeated Disinfection Durability

129 CFR Ch. XVII 1910.134 (h) (1) & Appendix B-2: Employer shall ensure that respirators are cleaned and disinfected using the procedures in Appendix B-2; the importance of thorough rinsing cannot be overemphasized. Detergents or disinfectants that dry on facepieces may result in dermatitis. In addition, some disinfectants may cause deterioration of rubber or corrosion of metal parts if not completely removed. 442 CFR 84.61 (d) Mouthpieces, hoods and facepieces, except those employed in single use respirators, shall be constructed of materials which will withstand disinfection as recommended by the applicant in his instructions for use of the device. 442 CFR 84.62 (3) assembled to permit easy access to parts which require periodic cleaning and disinfecting

Respirators should be durable enough for the respirator to provide a Simulated Workplace Protection Factor of > 100 after 50 disinfections, each taking 60 seconds or less to complete.

1

Shelf-life Durability X

Respirators should be durable enough for the respirator to provide a Simulated Workplace Protection Factor of > 100 after being stored in air-conditioned space for 10 years at 21-23ºC (69-73ºF) and 45-55% relative humidity.

2

Gauging Fit

Elastomeric

129 CFR Ch. XVII 1910.134 (g) (B) (iii) - For all tight-fi tting respirators, the employer shall ensure that employees perform a user seal check each time they put on the respirator using the procedures in Appendix B-1 or procedures recommended by the respirator manufacturer that the employer demonstrates are as effective as those in Appendix B-1 of this section.

Respirators should have a manufacturer-specifi ed fi t assessment technique (e.g., a user seal check) that is capable of detecting inadequate fi t (Simulated Workplace Protection Factor < 100) with at least 75% accuracy during work activities.

2

Filtering facepiece

129 CFR Ch. XVII 1910.134 (g) (B) (iii) - For all tight-fi tting respirators, the employer shall ensure that employees perform a user seal check each time they put on the respirator using the procedures in Appendix B-1 or procedures recommended by the respirator manufacturer that the employer demonstrates are as effective as those in Appendix B-1 of this section.

Respirators should have a manufacturer-specifi ed fi t assessment technique (e.g., a user seal check) that is capable of detecting inadequate fi t (Simulated Workplace Protection Factor < 100) with at least 75% accuracy during work activities.

5


Hearing Integrity X

(a) Specifi c word intelligibility tests should be developed, standardized and validated to more precisely measure the hearing accuracy of words in the healthcare setting and (b) Respirator wearers should achieve equivalent or higher scores on hearing acuity tests, on average, when wearing a respirator compared to no respirator.

1


1OSHA Standard 29 CFR Ch. XVII 1910.134 8Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notifi cation 2VA Tuberculosis Exposure Control Plan, August 14, 2008 [510(k)] Submissions, March 5, 20043VA Respiratory Protection Program, October 26, 2006 9FDA - About Personal Protective Equipment: www.fda.gov/cdrh/ppe/about.4NIOSH 42 CFR Ch. 1 Part 84 html5Respirator Selection Logic for particulate respirators 2004: http://www.cdc. 10www.aiha.org/Content/InsideAIHA/Standards/z88.htmgov/niosh/docs/2005-100/ 11www.iso.org6NIOSH Guide to the Selection and Use of Particulate Respirators - Certifi ed 12www.astm.orgUnder 42 CFR 84, January 1996 13BWG: BREATHE Working Group7MMWR, Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005




Speech Intelligibility X

Respirator wearers should achieve equivalent or higher scores on speaking intelligibility tests, on average, when wearing a respirator compared to no respirator.

1

Visual Field

442 CFR Ch. 1 84.176 Facepieces, hoods, and helmets shall be designed and constructed to provide adequate vision which is not distorted by the eyepieces.

(a) Visual fi elds should be assessed with a standardized and validated tool developed for use in the healthcare environment and (b) Healthcare visual fi eld performance criteria should be developed for respirator wearers.

2

Facial Visualization X

(a) Transparent respirator facepieces should be developed and, if possible, implemented and (b) Transparency should be assessed with an optical clearance test that is standardized and validated.

5

Equipment Compatibility

442 CFR Ch. 1 84.175 (e) Facepieces, hoods, and helmets shall be designed to prevent eyepiece fogging and (f) Half-mask facepieces shall not interfere with the fi t of common industrial safety corrective spectacles; 129 CFR Ch. XVII 1910.134 (g) (1) (B) (ii) If an employee wears corrective glasses or goggles or other personal protective equipment, the employer shall ensure that such equipment is worn in a manner that does not interfere with the seal of the facepiece to the face of the user.

(a) Respiratory protective equipment should be assessed for inter-equipment compatibility using a practical clinical test that should be developed, standardized, and validated and (b) Healthcare performance criteria for protective equipment compatibility should be developed.

2

Comfort & Tolerability

Breathing Resistance

442 CFR Ch. 1 84.180 (b) Resistance for particulate respirators upon initial inhalation shall not exceed 35 mm water column height pressure and upon initial exhalation shall not exceed 25 mm water column height pressure; 8Recommend differential pressure be evaluated for surgical masks that are not NIOSH certifi ed N95 Respirators; surgical masks that are NIOSH certifi ed N95 Respirators must meet NIOSH N95 requirements for differential pressure.

(a) Respirators should have a level of breathing resistance that is low enough to be comfortable & tolerable for (1) > 2 hours of uninterrupted wear and (2) > 8 hours with 15 minute break periods every 2 hours and (b) Breathing resistance should be < 10 mm water pressure drop on average at 85 lpm.

1

Facial Irritation

442 CFR Ch. 1 84.61 (b) Respirator components which come in to contact with the wearer’s skin shall be made of nonirritating materials; 8Recommended that biocompatibility of materials be evaluated as described in the standard ISO 10993, “Biological Evaluation of Medical Devices Part I: Evaluation and Testing.”

Facial irritation should be assessed using two standardized and validated tests: (a) A clinical assessment utilizing a pain or discomfort scale and (b) A lab-based sensitivity test, such as a transdermal water loss test or an animal skin sensitivity test.

1

Allergenicity

9Recommended that biocompatibility of materials be evaluated as described in the standard ISO 10993, “Biological Evaluation of Medical Devices Part I: Evaluation and Testing.” 442 CFR 84.62 (a) The component parts of each respirator shall be: (1) designed, constructed and fi tted to insure against creation of any hazard to the wearer.

(a) Immune system stimulation should be assessed with a standardized and validated test and (b) Performance characteristics for allergenicity should be developed.

1






Facial Pressure

129 CFR Ch. XVII 1910.134 Appendix A Part I (A) (6) Assessment of comfort shall include a review of the following points with the test subject and allowing the test subject adequate time to determine the comfort of the respirator: (a) position of the mask on the nose & (d) position of mask on face and cheeks; 129 CFR Ch. XVII 1910.134 Appendix A Part I (A) (7) The following criteria shall be used to help determine the adequacy of the respirator fi t: (b) adequate strap tension, not overly tightened; 442 CFR Ch. 1 84.178 (a) - All facepieces shall be equipped with head harnesses designed and constructed to provide adequate tension during use and an even distribution of pressure over the entire area in contact with the face; 442 CFR Ch. 1 84.178 (b) Facepiece head harnesses, except those employed on single-use respirators, shall be adjustable and replaceable.

(a) Respirator facial pressure should be low enough to be comfortable and tolerable for (1) > 2 hours of uninterrupted wear and (2) > 8 hours with 15 minute break periods every 2 hours and (b) Facial pressure should be assessed using two standardized & validated tests: a clinical assessment & a lab-based test.

2

Facial Heat X

(a) Respirators should cause a level of facial heat rise that is low enough to be comfortable for (1) > 2 hours of uninterrupted wear and (2) > 8 hours with 15 minute break periods every 2 hours and (b) Facial heat should not exceed a 7º (F) rise from baseline, on average, when the wearer is under low level exertion at 21-23ºC (69-73ºF) ambient temperature and 45-55% relative humidity.

2

Air Exchange

8Recommend differential pressure be evaluated for surgical masks that are not NIOSH certifi ed N95 Respirators; surgical masks that are NIOSH certifi ed N95 Respirators must meet NIOSH N95 requirements for differential pressure.

(a) Respirator C0 dead space retention should be 2low enough to be comfortable for (1) > 2 hours of uninterrupted wear and (2) > 8 hours with 15 minute break periods every 2 hours and (b) Respirator chamber C0 levels at end-inhalation 2should be < 2% on average.

2

Moisture Management X

(a) Respirator humidity should be maintained at levels perceived as comfortable for (1) > 2 hours of uninterrupted wear and (2) > 8 hours with 15 minute break periods every 2 hours and (b) Respirator relative humidity levels should be maintained at < 20% above baseline, on average, under low levels of exertion.

3

Mass Features X

(a) Respirator weight should be low enough, and distribution of weight suffi ciently symmetrical, to be comfortable and tolerable for (1) > 2 hours of uninterrupted wear and (2) > 8 hours with 15 minute break periods every 2 hours and (b) Respirator weight and mass distribution should be evaluated with a standardized and validated practical performance test for which performance criteria are developed.

3

Odor X(a) Odor should be assessed with a standardized and validated clinical tool and (b) Performance criteria should be developed.

3






Respirators should be comfortable enough to be worn for 10 consecutive days under the following circumstances: (1) > 2 hours of uninterrupted

Prolonged Tolerability X wear and (2) > 8 hours with 15 minute break

periods every 2 hours and (b) Perceived respirator 1

discomfort during prolonged wear should be assessed clinically using a validated and standardized test, such as a visual analogue scale.

Healthcare Systems Policies & Practices

Employer Desirability X

Employer interviews, surveys and clinical trials should be conducted to determine respirator features that would lead employers to purchase one respirator over another.

1

Employee Desirability X

Employee interviews, surveys and clinical trials should be conducted to determine respirator features that would lead employees to choose one respirator over another.

1

Patient & healthcare visitor interviews and surveys

Patient Desirability X should be conducted to determine respirator features that would lead them to prefer one 2

respirator over another.

Cost Effective for Employers X

(a) Studies that estimate the costs and benefi ts of respirators across diverse settings should be completed and (b) Health economists and other fi scal experts should be recruited for participation in cost-effectiveness assessments.

2




TABLE 3: FORTHCOMING RESPIRATOR PERFORMANCE REQUIREMENTS ISSUED BY PERTINENT U.S.GOVERNMENTAL AGENCIES AND OVERSIGHT ORGANIZATIONS

AGENCY ANSI/AIHA1 ISO2 ASTM3




Z88.2 1992 Practices for Respiratory Protection; Z88.12 Respiratory Protection for Infectious Aerosols.

ISO/CD 16975 Respiratory Protective Devices - Selection, use, & maintenance. X

Self-Contamination X X X

Fomite Transmission X X X

Protection/Respirator Fit X

ISO/DIS 16900-1 Respiratory Protective Devices - Methods of Test & test equipment - Part 1: Determination of inward leakage; ISO/DIS 16900-3 Methods of Test & Test equipment - Part 3: Determination of particle fi lter penetration. ISO/CD TS 16976-2 Respiratory Protective Devices - Human factors Part 2: Anthropometrics.

X

Blood & Body Fluids X X

ASTM WK17678 Revision of F2100-07 Standard Specifi cation for Performance of Materials Used in Medical Face Masks; ASTM WK14697 Revision of F1862-07 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood.

ReuseZ88.2 1992 Practices for Respiratory Protection; Z88.12 Respiratory Protection for Infectious Aerosols.

ISO/CD 16975 Respiratory Protective Devices - Selection, use, & maintenance. X

Repeated Disinfection Durability

Z88.2 1992 Practices for Respiratory Protection; Z88.12 Respiratory Protection for Infectious Aerosols.

ISO/CD 16975 Respiratory Protective Devices - Selection, use, & maintenance.

ASTM WK19887 - New test method for evaluation of the effectivenss of biological decontamination procedures for air permeable materials when challenged by a viral aerosol; ASTM WK14697 Revision of F1862-07 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood; ASTM WK19888 - New Test Method for Evaluation of the Effectiveness of Biological Decontamination Procedures for Surfaces when Challenged with Viral Droplets.

Shelf-life Durability X X X

Gauging Fit

Elastomeric X

ISO/DIS 16900-1 Respiratory Protective Devices - Methods of Test & test equipment - Part 1: Determination of inward leakage.

X

Filtering facepiece X

ISO/DIS 16900-1 Respiratory Protective Devices - Methods of Test & test equipment - Part 1: Determination of inward leakage.

X

Abbreviations

AIHA - American Industrial Hygiene AssociationANSI - American National Standards InstituteASTM - American Society for Testing and MaterialsCDC - Centers for Disease and ControlFDA - Food and Drug AdministrationISO - International Organization for Standardization

References

1www.aiha.org/Content/InsideAIHA/Standards/z88.htm2www.iso.org. Accessed March 2009.3www.astm.org. Accessed March 2009


AGENCY ANSI/AIHA1 ISO2 ASTM3



Hearing Integrity X X X

Speech Intelligibility X X

Visual Field X X X

Facial Visualization X X X

Equipment Compatability X X

Comfort & Tolerability

Breathing Resistance X

ISO/DIS 16900-2 Respiratory Protective Devices - Methods of Test & test equipment - Part 2: Determination of breathing resistance.

ASTM WK17678 - Revision of F2100-07 Standard Specifi cation for Performance of Materials Used in Medical Face Masks.

Facial Irritation X X X

Allergenicity X X X

Facial Pressure X X X

Facial Heat X

ISO/DIS 16900-2 Respiratory Protective Devices - Methods of Test & test equipment - Part 2: Determination of breathing resistance.

X

Air Exchange X

ISO/CD TS 16976-3 Respiratory Protective Devices - Human factors Part 3: Physiological responses and limitations of oxygen and carbon dioxide in the breathing environment; ISO/NP 16900-9 Respiratory Protective Devices - Methods of Test & test equipment - Part 9: Carbon dioxide content of the inhaled air (dead space); ISO/CD TS 16976-2 Respiratory Protective Devices - Human factors Part 2: Anthropometrics.

ASTM WK17678 - Revision of F2100-07 Standard Specifi cation for Performance of Materials Used in Medical Face Masks.

Moisture Management X X

Mass Features X X X

Odor X X X

Prolonged Tolerability X X

Healthcare System Policies and Practices

Desired by employers X X

Desired by healthcare workers X X

Desired by patients X X X

Cost effective for employers X X

X

X

X

X

X

X

X

Abbreviations

AIHA - American Industrial Hygiene AssociationANSI - American National Standards InstituteASTM - American Society for Testing and MaterialsCDC - Centers for Disease and ControlFDA - Food and Drug AdministrationISO - International Organization for Standardization

References

1www.aiha.org/Content/InsideAIHA/Standards/z88.htm2www.iso.org. Accessed March 2009.3www.astm.org. Accessed March 2009


APPENDIX A: PROJECT BREATHE WORKING GROUP MEMBERSHIP LIST

Heinz Ahlers, JD Dave CarettiChief, Technology Evaluation Branch Research PhysiologistNational Personal Protective Technology Laboratory Edgewood Chemical Biological Center National Institute for Occupational Safety and Health U.S. Army Research Development and Engineering Command Centers for Disease Control and Prevention 5183 Blackhawk RoadP.O. Box 18070 Aberdeen Proving Ground, MD 21010-5424626 Cochrans Mill Road, Building 20

Karen M. Coyne, Ph.D.Pittsburgh, PA 15236Research General Engineer

Aliya Baig, RN, MSN, MPH Edgewood Chemical Biological Center Associate, National Center for Occupational Health and Infection U.S. Army Research Development and Engineering Command

Control 5183 Blackhawk RoadU.S. Department of Veterans Affairs Aberdeen Proving Ground, MD 21010-5424Veterans Health Administration

Victoria Davey, Ph.D., MPH, RN, (Co-Chair)Office of Public Health and Environmental Deputy Chief Consultant Hazards and North Florida/South Georgia Veterans Health Office of Public Health and Environmental HazardsSystemVeterans Health Administration 1601 SW Archer Road (151B)U.S. Department of Veterans Affairs Gainesville, Florida 326081717 H Street, Washington, DC 20420

Dan Barker Donald F. DoerrResearch AnalystChief, Biomedical EngineeringEdgewood Chemical Biological Center National Aeronautics and Space AdministrationU.S. Army Research Development and Engineering Command John F. Kennedy Space Center5183 Blackhawk RoadKennedy Space Center, FL 32899 Aberdeen Proving Ground, MD 21010-5424 Paul Gardner Michael Bell, MDChief, Respiratory Protection BranchAssociate Director for Infection Control, Division of Healthcare Edgewood Chemical Biological Center Quality PromotionU.S. Army Research Development and Engineering Command National Center for Preparedness, Detection, and Control of 5183 Blackhawk RoadInfectious DiseasesAberdeen Proving Ground, MD 21010-5424Centers for Disease Control and Prevention

1600 Clifton Road Corey GroveAtlanta, GA 30333 Chemical Engineer

Edgewood Chemical Biological Center Les BoordU.S. Army Research Development and Engineering Command Laboratory Director5183 Blackhawk RoadNational Personal Protective Technology Laboratory Aberdeen Proving Ground, MD 21010-5424National Institute for Occupational Safety and Health

Centers for Disease Control and Prevention Lorraine Messinger Harkavy, RN, MSP.O. Box 18070 Project Officer626 Cochrans Mill Road, Building 20 Office of the Assistant Secretary for Preparedness and Response Pittsburgh, PA 15236 Biomedical Advanced Research and Development Authority

Division of Influenza and Emerging Diseases Rodney A. Bryant, Ph.D.330 Independence Avenue, SW, Room G640Mechanical EngineerWashington, DC 20201National Institute of Standards and Technology

Building and Fire Research Laboratory Michael Hodgson, MD, MPHGaithersburg, MD 20899 Chief Consultant

Occupational Health, Safety, and Prevention Strategic Healthcare Kathryn M. Butler, Ph.D.Group National Institute of Standards and Technology

Office of Public Health and Environmental HazardsBuilding and Fire Research LaboratoryVeterans Health Administration 100 Bureau Drive Stop 8665U.S. Department of Veterans Affairs Gaithersburg, MD 20899-8665 1717 H StreetWashington, DC 20420


Paul A. Jensen, Ph.D. Raymond Roberge, MD, MPH Engineer Director Research Medical OfficerDivision of Tuberculosis Elimination National Personal Protective Technology LabNational Center for HIV, Viral Hepatitis, STD, and TB National Institute for Occupational Safety and Health

Prevention Centers for Disease Control and PreventionCoordinating Center for Infectious Diseases P.O. Box 18070Centers for Disease Control and Prevention 626 Cochrans Mill Road, Building 291600 Clifton Road NE Pittsburgh, PA 15236Atlanta, GE 30333

Ronald E. Shaffer, Ph.D. (Co-Chair)Caprice Knapp, Ph.D. Chief, Research BranchAssociate, National Center for Occupational Health and Infection National Personal Protective Technology Laboratory

Control National Institute for Occupational Safety and HealthU.S. Department of Veterans Affairs Centers for Disease Control and PreventionVeterans Health Administration P.O. Box 18070Office of Public Health and Environmental 626 Cochrans Mill Road, Building 29Hazards and North Florida/South Georgia Veterans Health Pittsburgh, PA 15236

SystemJohn Steelnack1601 SW Archer Road (151B)Industrial HygienistGainesville, Florida 32608Office of Biological Hazards

Andrew Levinson, MPH Directorate of Standards and GuidanceDirector U.S. Department of LaborOffice of Biological Hazards Occupational Safety and Hazards AdministrationOSHA Directorate of Standards and Guidance 200 Constitution Avenue200 Constitution Avenue NW, Room N3718 Washington, D.C. 20210Washington, DC 20210

Jonathan Szalajda, MSBill Newcomb Chief, Policy and Standards Development BranchEngineer National Personal Protective Technology LaboratoryNational Personal Protective Technology Laboratory National Institute for Occupational Safety and HealthNational Institute for Occupational Safety and Health Centers for Disease Control and PreventionCenters for Disease Control and Prevention P.O. Box 18070P.O. Box 18070 626 Cochrans Mill Road, Building 401626 Cochrans Mill Road, Building 402 Pittsburgh, PA 15236Pittsburgh, PA 15236

Renée L. Szybala, JDJay Parker, CIH Associate General CounselEngineer U.S. Department of Veterans AffairsNational Personal Protective Technology Laboratory 810 Vermont AvenueNational Institute for Occupational Safety and Health Washington, DC 20420Centers for Disease Control and Prevention

W. Jon Williams, Ph.D.P.O. Box 18070Research Physiologist626 Cochrans Mill Road, Building 20National Personal Protective Technology Lab Pittsburgh, PA 15236ational Institute for Occupational Safety and Health

Lewis J. Radonovich, Jr., MD (Co-Chair) Centers for Disease Control and PreventionDirector, Center for Occupational Health and Infection Control P.O. Box 18070U.S. Department of Veterans Affairs 626 Cochrans Mill Road, Building 29Veterans Health Administration Pittsburgh, PA 15236Office of Public Health and Environmental Hazards and North

Florida/South Georgia Veterans Health System1601 SW Archer Road (151B)Gainesville, FL 32608

Irene L. Richardson, MSIndustrial HygienistIndustrial Hygiene Field Services ProgramU.S. Army Center for Health Promotion and Preventive Medicine5158 Blackhawk RoadAberdeen Proving Ground, MD 21010-5403

http://www.publichealth.va.gov/about/cohic National Center for Occupational Health and Infection Control Office of Public Health and Environmental Hazards Veterans Health Administration Department of Veterans Affairs Washington, DC 20420 2009

Documents

BETTER RESPIRATORY EQUIPMENT USING ADVANCED …BETTER RESPIRATORY EQUIPMENT USING ADVANCED TECHNOLOGIES FOR HEALTHCARE EMPLOYEES (PROJECT B.R.E.A.T.H.E.) An Interagency Working Group